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FMP™ Surgical Technique

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FMP® Surgical Technique

ContentsDesign Rationale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Preoperative Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Surgical Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Acetabular Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Acetabular Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Screw Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

DJO Surgical is a manufacturer of orthopedic implants and does not practice medicine. Only an orthopedic surgeon can determine what treatment is appropriate. Individual results of total joint replacement may vary. The life of any implant will depend on the patient’s weight, age, activity level, and other factors.

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FMP® Acetabular System

DESIGN RATIONALEThe FMP Acetabular System consists of the following:

Porous hemispherical acetabular shell with clustered screwholes

Porous flared rim acetabular shell with clustered screwholes

Porous hemispherical acetabular shell without screwholes

Porous flared rim acetabular shell without screwholes

Porous hemispherical acetabular shell with three spikes

Porous hemispherical acetabular shell with multiple holes

Various compression molded and X-alt™ highly cross-linked polyethylene liners

Constrained Liner

• 22, 28, 32, 34, 36, 40 and 44mm modular CoCr femoral heads

• 28 and 32mm modular Alumina ceramic femoral heads

• 28, 32, 36, 40 and 44mm BIOLOX® delta and delta option ceramic

• femoral heads

• Bipolar heads

• Unipolar heads and modular neck adaptor sleeves

The six metal-backed porous coated acetabular shells feature a thin-wall design that allows for maximum polyethylene thickness of the acetabular liner inserts . All are designed and manufactured with high congruency between the modular liner and the Titanium metal shell . The snap-fit acetabular liners are available in neutral, 10º, 20º, neutral with a 5mm offset and 10º with a 5mm offset . All inserts are sterilized by gamma radiation in a nitrogen-flushed environment . Sterilization of the Highly Cross-Linked Polyethylene Acetabular Liner, Highly Cross-Linked Polyethylene Vitamin E Acetabular Liner, and FMP Extended Liner is performed by hydrogen peroxide gas plasma to achieve a Sterility Assurance Level (SAL) of 10-6 .

The flared rim shell provides an additional 2mm of peripheral contact for increased stability, while the spiked cup features three spikes for increased rotational stability . The bipolar features a modular snap-fit design utilizing 22mm and 28mm modular femoral heads . The unipolar heads range in size from 42-64mm and feature five neck adaptor sleeve options .

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FMP® Acetabular SystemINDICATIONSJoint replacement is indicated for patients suffering from disability due to:

• Noninflammatory degenerative joint disesase including osteoarthritis and avascular necrosis of the natural femoral head;

• Rheumatoid arthritis

• Correction of functional deformity

• Femoral fracture

This device may also be indicated in the salvage of previously failed surgical attempts .

The constrained acetabular component is indicated for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for who all other options to constrained acetabular components have been considered . This device is to be used for uncemented applications .

CONTRAINDICATIONSJoint replacement is contraindicated where there is:

• Infection or sepsis;

• Insufficient bone quality which may affect the stability of the implant;

• Muscular, neurological or vascular deficiencies, which compromise the affected extremity;

• Skeletally immature patients and cases where there is a loss of abductor musculature, poor bone stock, poor skin coverage around the hip joint which would make the procedure unjustifiable;

• Osteomyelitis;

• Rapid joint destruction or bone absorption apparent on roentgenogram; Pathological conditions of the acetabulum, which would prevent achieving proper range of motion, appropriate head stability, and/or a well-seated and supported smooth articulation of the head within the acetabulum;

• Alcoholism or other addictions;

52mm

• Materials sensitivity;

• Loss of ligamentous structures;

• High levels of physical activity (e .g . competitive sports, heavy physical labor);

• Pregnancy (contraindicated for Metal on Metal applications only)

PREOPERATIVE PLANNINGPreoperative templates are provided for estimating the optimal acetabular component size . Radiographs should include a full A/P (anterioposterior) and lateral view of the pelvis .

As with any surgical procedure, proper radiographs are required for accurate templating .

The dotted line of the shell represents the outer dimension of the porous shells . The flared rim design is 2mm larger (1mm per side) at the rim . (FIGURE 1)

FIGURE 1

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ACETABULAR PLACEMENTThe dome plug is removed from the acetabular shell (FIGURE 2) and the shell is attached to the positioner instrument (FIGURE 3) . If a screwhole design shell is selected, the cluster of screwholes may be positioned to the posterior/superior quadrant of the acetabulum . The T-handle is inserted in either the 15º or 20º position depending on the desired degree of anteversion . The alignment rod is threaded into either the left or right alignment hole of the positioner (FIGURE 4) .

Aligning the rod of the T-handle perpendicular to the patient gives approximately 45º of abduction . Then, positioning the alignment rod parallel to the patient’s midline gives approximately 20º or 15º of anteversion depending on the selected position of the alignment rod (FIGURE 5) .

FIGURE 2 FIGURE 3

FIGURE 4 FIGURE 5

FMP® Acetabular SystemSURGICAL APPROACHThe FMP Acetabular System is designed to accommodate any standard approach based on the surgeon’s experience or personal preference . Adequate exposure, which allows bony landmark visualization, component alignment, and thorough soft-tissue assessment, can contribute to more successful results .

ACETABULAR PREPARATIONThe acetabular rim is exposed by thorough removal of the acetabular labrum . The acetabular fat pad and any osteophytes are removed to identify the true acetabular floor .

An acetabular reamer, 3-4mm smaller than the templated shell size, is used to deepen the true acetabular floor . Placing each reamer concentrically into the acetabulum, the reaming progresses in 2mm increments until good contact is made with the cortical rim . In a shallow acetabulum, it may be necessary to ream to the medial cortical wall . In an eccentrically deep acetabulum, the cotyloid notch may be left intact . All cysts are curetted and subsequent defects may be packed with cancellous bone obtained from the resected femoral head or acetabular bone reamings .

The final reamed diameter should be the same as or 1mm smaller than the selected implant size, depending on the quality of the bone . In normal to sclerotic bone, a line-to-line reaming is sufficient . In soft bone, under reaming by 1mm may be necessary . If the flared rim cup is selected for implantation, a line-to-line reaming will allow 2mm press-fit around the rim of the acetabulum . If the acetabulum is under reamed by 1mm, a flared rim cup will allow a 1mm press-fit over the hemisphere and a 3mm press-fit around the rim of the acetabulum .

Shell trial gauges are available in even sizes in 2mm increments to verify ream diameter . The shell trial should make even contact with the rim and walls of the acetabulum and provide feedback that the acetabulum has been prepared adequately for the final implant .

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FMP® Acetabular SystemSCREW PLACEMENTThe flexible drill shaft and drill bit are guided by the drill guide through the desired screwhole (FIGURE 6) . The drill guide is 15mm in length; drill bits are available in 45mm or 60mm lengths and 3 .2mm or 4 .5mm diameters . The working length of the drill bit extending from the drill guide is 30mm and 45mm respectively . A depth gauge is provided to determine the length of the screw needed and to verify that the internal cortex has not been penetrated (FIGURE 7) .

The appropriate cancellous bone screw is inserted using the universal joint screwdriver and the screw forceps (FIGURE 8) .

NOTE: The bone screw must be fully seated to ensure full seating of the implant liner.

FIGURE 6

FIGURE 7

FIGURE 8

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FMP® Acetabular SystemLINER TRIALING AND IMPLANTATIONThe appropriate insert is determined for best femoral head coverage and joint stability . Polyethylene inserts are available in neutral standard, neutral 5mm offset, 10º standard, 10º 5mm offset, 20º hooded and constrained designs . The 12-position scallops on the various inserts allow independent rotation of the insert to the point where additional femoral head coverage is desired . Trial liners can be threaded into the implant shell so that a trial reduction can be performed to assist in final implant selection (FIGURE 9) . At this point, measurements of the offset and neck length can be compared to the preosteotomy measurements, but may need to be adjusted to ensure adequate/optimal stability depending on final acetabular component seating and anteversion of the femoral stem . Neck length can be adjusted using the various offsets of the femoral head implants .

Once the appropriate liner has been determined, the trial liner can be removed and the dome plug can be replaced into the shell (FIGURE 10) . The final liner implant is then impacted into the shell using the liner impactor head that corresponds to the implant head size being used (FIGURE 11) . Visually confirm symmetrical seating of the polyethylene liner . An osteotome can be lightly inserted between the shell and the inserted liner . Gently attempt to pry upward on the polyethylene liner . There should be no movement of the liner within the shell . If the liner disengages, repeat the impaction until the snap-feature engages .

*Range of motion typically increases as femoral head size increases . If using a smaller femoral head, it is important to verify that sufficient range of motion is achieved .

NOTE: The use of offset sleeves is required with 34, 36, 40 and 44 mm CoCr heads.

FIGURE 9

FIGURE 10

FIGURE 11

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FMP® Acetabular System

If a constrained liner is being used, use standard trial liners and 28mm head trials to determine appropriate neck length . Once the desired sizing has been determined, impact the constrained liner implant using a 28mm ball impactor . To assemble the constrained liner components, first impact the femoral head implant onto the taper of the stem implant . Next, slide the constrained locking ring over the neck of the femoral stem implant so that the locking feature is oriented to correctly engage the liner . Insert the femoral head into the constrained line (FIGURE 12) . Last, snap the locking ring onto the locking scallops of the constrained liner (FIGURE 13) . This can be achieved by hand .

FIGURE 12

FIGURE 13

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FMP® Acetabular System Product Reference GuideThe FMP system uses letters, colors and numbers to designate compatibility between all components . Matching shell and insert codes will ensure proper compatibility . For more implant part numbers and information, please refer to the Acetabular Reference Guide (catalog number 0020327-001) .

COLOR/CODE STANDARD SHELL SIZE

SPIKED SHELL SIZE ID/HEAD SIZE NEUTRAL/0° 10° HOODED 20° HOODED 5MM OFFSET

NEUTRAL/0°5MM OFFSET 10° HOODED

MIN POLY THICKNESS

HXE+ X-ALT HXE+ X-ALT HXE+ X-ALT X-ALT X-ALT STD SHELL

MP1* 40 N/A 22MM – – – – – – – – 5.6

MP2* 42 N/A 22MM – – – – – – – – 6.7

MP3* 44 N/A 22MM – – – – – – – – 7.6

MP4 46 N/A 28MM 931-28-746 931-28-246 932-28-746 932-28-246 933-28-746 933-28-246 934-28-246 935-28-246 5.8

MP5 48 48/50 28MM 931-28-748 931-28-248 932-28-748 932-28-248 933-28-748 933-28-248 934-28-248 935-28-248 6.1

MP6 50 5232MM 931-32-750 931-32-250 932-32-750 932-32-250 933-32-750 933-32-250 – – 5.8

34MM 931-34-750 931-34-250 932-34-750 932-34-250 933-34-750 933-34-250 934-34-250 935-34-250 4.8

MP7 52 5432MM 431-32-707 – 432-32-707 – 433-32-707 – – – 6.8

36MM 931-36-752 931-36-252 932-36-752 932-36-252 933-36-752 933-36-252 934-36-252 935-36-252 4.8

MP8 54 5632MM 431-32-708 – 432-32-708 – 433-32-708 – – – 7.8

36MM 931-36-754 931-36-254 932-36-754 932-36-254 933-36-754 933-36-254 934-36-254 935-36-254 5.8

MP9 56/58 58/60

32MM 431-32-709 – 432-32-709 – 433-32-709 – – – 8.8

36MM 931-36-756 931-36-256 932-36-756 932-36-256 933-36-756 933-36-256 934-36-256 935-36-256 6.8

40MM 931-40-756 931-40-256 932-40-756 932-40-256 933-40-756 933-40-256 934-40-256 935-40-256 4.8

MP10 60/62 62/64

32MM 431-32-710 – 432-32-710 – 433-32-710 – – – 10.8

36MM 931-36-760 931-36-260 932-36-760 932-36-260 933-36-760 933-36-260 934-36-260 935-36-260 8.8

40MM 931-40-760 931-40-260 932-40-760 932-40-260 – – – – 6.8

44MM 931-44-760 931-44-260 932-44-760 932-44-260 933-44-760 933-44-260 934-44-260 935-44-260 4.8

MP11 64/66 66/68

32MM 431-32-711 – 432-32-711 – 433-32-711 – – – 12.8

36MM 931-36-764 931-36-264 932-36-764 932-36-264 933-36-764 933-36-264 934-36-264 935-36-264 10.8

40MM 931-40-764 931-40-264 932-40-764 932-40-264 – – – – 8.8

44MM 931-44-764 931-44-264 932-44-764 932-44-264 933-44-764 933-44-264 934-44-264 935-44-264 6.8

MP12 68/70 70

32MM 431-32-712 – 432-32-712 – 433-32-712 – – – 14.8

36MM 931-36-768 931-36-268 932-36-768 932-36-268 933-36-768 933-36-268 934-36-268 935-36-268 12.8

40MM 931-40-768 931-40-268 932-40-768 932-40-268 – – – – 10.8

44MM 931-44-768 931-44-268 932-44-768 932-44-268 933-44-768 933-44-268 934-44-268 935-44-268 8.8

MP13* 72/74 N/A

36MM 931-36-772 931-36-272 932-36-772 932-36-272 933-36-772 933-36-272 934-36-272 935-36-272 14.8

40MM 931-40-772 931-40-272 932-40-772 932-40-272 – – – – 12.8

44MM 931-44-772 931-44-272 932-44-772 932-44-272 933-44-772 933-44-272 934-44-272 935-44-272 10.8

MP14* 76/78 N/A

36MM 931-36-776 931-36-276 931-36-776 932-36-276 933-36-776 933-36-276 934-36-276 935-36-276 16.8

40MM 931-40-776 931-40-276 931-40-776 932-40-276 – – – – 14.8

44MM 931-44-776 931-44-276 931-44-776 932-44-276 933-44-776 933-44-276 934-44-276 935-44-276 12.8

MP15* 80 N/A

36MM 931-36-780 931-36-280 931-36-780 932-36-280 933-36-780 933-36-280 934-36-280 935-36-280 18.8

40MM 931-40-780 931-40-280 931-40-780 932-40-280 – – – – 16.8

44MM 931-44-780 931-44-280 931-44-780 932-44-280 933-44-780 933-44-280 934-44-280 935-44-280 14.8

HXE+ AND X-ALT HIGHLY CROSS-LINKED LINERS

*Denotes special request *22mm liners (MP1-MP3) available in compression molded only. *Poly thickness is measured 30 degrees from the dome.

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FMP® Acetabular System Product Reference Guide

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ADDITIONAL INSTRUMENTATIONWhen using the straight cup impactor, part number 803-05-337, one of the three modular impaction tips must be used when impacting the shell . Place the impaction tip over the straight cup impactor threads until you feel it snap into place . The impactor threads should be exposed to screw into the shell . The small tip should be used for shell sizes 40-46mm, the medium tip for 48-58mm, and the large tip for 60-70mm .

With this straight cup impactor there are two alignment guide options: supine and lateral . The guides will provide 20 degrees of anteversion (vertical rod for supine guide, horizontal rod for lateral guide) and 45 degrees of inclination (horizontal rod for supine guide, vertical rod for lateral) . First, thread an alignment rod into the threaded hole on top of the selected guide . Thread the second alignment rod into either the left or right threaded hole . Place the assembly onto the handle of the impactor with the guide label and description facing the modular impaction tip . Rotate the guide into the desired position and secure by tightening the knob .

When the horizontal alignment rod aligns with the patient’s spine and the vertical rod is perpendicular to the floor, the handle will be oriented at 20˚ of anteversion and 45̊ of inclination .

DJO Surgical I A DJO Global CompanyT 800.456.8696 D 512.832.9500 F 512.834.6300

9800 Metric Blvd. I Austin, TX 78758 I U.S.A.djoglobal.com/djosurgical

0020308-001 Rev F 02/17

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.

See package insert for a complete listing of

indications, contraindications,warnings, and precautions.

©2017 Encore Medical, L.P.

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