BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 71MM

    MDR report key: 5880562 · Received August 16, 2016

    Report

    Report Number
    0001825034-2016-03109
    Event Type
    Injury
    Date Received
    August 16, 2016
    Date of Event
    October 31, 2016
    Report Date
    March 9, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." UNDER WARNINGS, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS." DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT PRODUCTS - BEARING - CATALOGUE: 183440 LOT 620200; TIBIAL TRAY - CATALOGUE: 141233 LOT 399900.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: FEMUR - CATALOGUE: 183050 LOT: 997950; TIBIAL BEARING - CATALOGUE: 183440 LOT: 620200; SIGNATURE GUIDE - CATALOGUE: 42-422561 LOT: 016132; BONE CEMENT - CATALOGUE: 402283 LOT: 853920. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO USE/USER ERROR. IT WAS REPORTED THAT THE TIBIAL COMPONENT WAS IMPLANTED WITH GREATER THAN 20 DEGREES OF INTERNAL ROTATION. SURGICAL TECHNIQUE (B)(4) NOTES TO THE USER TO TAKE EXTRA CAUTION TO AVOID INTERNAL ROTATION OF THE TIBIAL TRAY DUE TO THE PRESENCE OF LATERAL SOFT TISSUE ON PAGE 26. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE.

    Description of Event or Problem · 1

    A RIGHT KNEE REVISION PROCEDURE HAS BEEN INDICATED APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO ALLEGED SURGEON ERROR. IT WAS REPORTED THE FEMORAL COMPONENT WAS INITIALLY IMPLANTED WITH MORE THAN 20 DEGREES OF INTERNAL ROTATION. THE PATIENT IS CURRENTLY UNABLE TO WALK. DUE TO PATIENT'S BONE CONDITION, ONLY THE BEARING WILL BE REVISED. NO REVISION HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO ALLEGED SURGEON ERROR. IT WAS REPORTED THE FEMORAL COMPONENT WAS INITIALLY IMPLANTED WITH MORE THAN 20 DEGREES OF INTERNAL ROTATION. THE PATIENT IS CURRENTLY UNABLE TO WALK. DUE TO PATIENT'S BONE CONDITION, ONLY THE PATELLA WAS RESURFACED AND THE BEARING WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT KNEE REVISION PROCEDURE APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO ALLEGED SURGEON ERROR. IT WAS REPORTED THE TIBIAL COMPONENT WAS INITIALLY IMPLANTED WITH MORE THAN 20 DEGREES OF INTERNAL ROTATION. THE PATIENT IS CURRENTLY UNABLE TO WALK. DUE TO PATIENT'S BONE CONDITION, ONLY THE PATELLA WAS RESURFACED AND THE BEARING WAS REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531556 BIOMET CC CRUCIATE TRAY 71MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 399900

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R| S