BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 6, 13MM

    MDR report key: 18835393 · Received March 5, 2024

    Report

    Report Number
    1038671-2024-00393
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    June 15, 2023
    Report Date
    November 27, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048554
    PMA / PMN Number
    K933610
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: 0806283 204-01-06 - PS CEMENTED FEMORAL SZ 6, 0976352 204-04-65 - TRAPEZOID TIBIAL TRAY SZ 6F/5T, 1251562 200-02-38 - THREE PEG PATELLA 38MM. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.NO OTHER INFORMATION AVAILABLE. PENDING INVESTIGATION

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B1 B2 G1 H6 THE FOLLOWING SECTIONS WERE CORRECTED: E1 H6 THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B1- BOTH ADVERSE EVENT AND PRODUCT PROBLEM B2- BOTH HOSPITALIZATION - INITIAL OR PROLONGED AND REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES) THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2009, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 13 YEARS AND 8 MONTHS AFTER INITIAL IMPLANT. PER POSTOPERATIVE DIAGNOSIS STATED IN OP REPORT: FAILED RIGHT KNEE (ADVANCED WEAR OF POLYETHYLENE LINER WITH SEVERE SOFT TISSUE REACTION. REVISED TO COMPETITOR'S DEVICES (FEMORAL, TIBIAL, AND PATELLA COMPONENTS). NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476438 PS TIBIAL INSERTS SZ 6, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862048554

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Hospitalization| R SEE H10.