BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 4, 11MM

    MDR report key: 16480377 · Received March 3, 2023

    Report

    Report Number
    1038671-2023-00346
    Event Type
    Injury
    Date Received
    March 3, 2023
    Date of Event
    January 15, 2018
    Report Date
    June 24, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048394
    PMA / PMN Number
    K933610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 2955632 200-02-32 - THREE PEG PATELLA 32MM; 33039 203-96-01 - (11-2222) SAW BLADE NEW STRYK (.050); 28253 203-96-02 - (11-2324) SAW BLADE NEW STRYK (.035); 3003748 204-04-44 - TRAPEZOID TIBIAL TRAY SZ 4F/4T; 1735336 234-03-04 - OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 4. RECALL/CORRECTION NUMBER: Z-0019-2022.

    Additional Manufacturer Narrative · 0

    H11. ADDITIONAL MANUFACTURER NARRATIVE- ADDITIONAL INFORMATION WAS ADDED. H3. INVESTIGATION RESULTS- THE REVISION REPORTED WAS LIKELY THE RESULT OF WEAR OF THE TIBIAL INSERT. THE CAUSE AND EXTENT OF THE TIBIAL INSERT WEAR, AS WELL AS THE ALLEGED MISALIGNMENT, CANNOT BE DETERMINED BECAUSE THE REVISED COMPONENTS WERE NOT RETURNED FOR EVALUATION AND NO IMAGES OR RADIOGRAPHS WERE PROVIDED. A CONTRIBUTING FACTOR TO THE WEAR OF THE TIBIAL INSERT MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. A PRODUCT RECALL WAS INITIALLY ISSUED IN 2021 AND EXPANDED IN 2022 FOR THE POLYETHYLENE TIBIAL INSERTS PACKAGED IN NON-CONFORMING BAGS. ADDITIONAL CORRECTIONS NOR CORRECTIVE ACTIONS ARE REQUIRED BECAUSE THE FAILURE CANNOT BE CONFIRMED, THE OCCURRENCE RATE IS ¿VERY LOW¿, THE IDENTIFIED RISKS RELATED TO THIS FAILURE IS LISTED IN THE PRODUCT LABELING (IFU 700-096-004 REV T) AND IS WITHIN THE LEVEL ASSESSED IN THE CURRENT RISK MANAGEMENT FILE. A REVIEW OF THE RISK MANAGEMENT REPORT WAS CONDUCTED TO ENSURE THE RISK WAS INCLUDED AND THE OCCURRENCE IS BELOW THE THRESHOLD. THIS DOES NOT APPEAR TO BE A DESIGN RELATED ISSUE AS THE COMPLAINT OCCURRENCE RATED IS VERY LOW. CORRECTION¿ F6 & F8 SHOULD BE BLANK. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY LEGAL NOTIFICATION, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2014. THE PATIENT HAD A TIBIAL EXCHANGE ON (B)(6) 2018 DUE TO MALALIGNMENT AND THE DEFECTIVE NATURE OF THE DEVICE. DUE TO THE SURGEON PLACING THE LEG AND/OR COMPONENTS IN MALALIGNMENT, THIS CAUSED OR CONTRIBUTED TO THE PATIENT SUSTAINING DAMAGES TO HIS RIGHT KNEE AND SUFFER ONGOING PAIN, SWELLING, MALFUNCTION, AND NEED FOR ADDITIONAL SURGERIES. THE TIBIAL INSERTS' TENDENCY TOWARDS EARLY FAILURE AND THE CREATION OF EXCESSIVE DEBRIS AND FAILURE TO CONFORM TO SPECIFICATIONS WAS MADE WORSE BY MISALIGNMENT, AND THE MISALIGNMENT WAS MADE WORSE BY THE DEFECTIVE NATURE OF THE TIBIAL INSERTS, SO THAT THE PATIENT'S INSERT PREMATURELY FAILED AND HAD TO BE REMOVED AND REPLACED.

    Description of Event or Problem · 0

    DEVICE WAS IMPLANTED FOR APPROXIMATELY 3 YEARS AND 9 MONTHS. FROM REVISION OPERATIVE REPORT: PREOPERATIVE DIAGNOSIS: POLYETHYLENE WEAR. PATIENT WAS REVISED TO EXACTECH DEVICE. SURGEON NOTES SIGNIFICANT INTRAARTICULAR SYNOVITIS. POSTOPERATIVE DIAGNOSIS: POLYETHYLENE WEAR, INTRAARTICULAR SYNOVITIS. EXPLANTED POLY HAD NOTABLE EROSION OF THE MEDIAL COMPARTMENT AS WELL AS DEGENERATION OF THE POST. THE PATIENT WAS AWAKENED AND BROUGHT TO RECOVERY ROOM IN EXCELLENT CONDITION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2022520 PS TIBIAL INSERTS SZ 4, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 204-24-11 10885862048394

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention