BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 1, 11MM

    MDR report key: 18873503 · Received March 11, 2024

    Report

    Report Number
    1038671-2024-00445
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    May 2, 2018
    Report Date
    June 23, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048158
    PMA / PMN Number
    K933610
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10. D10. CONCOMITANTS: 200-03-32 - ONE PEG PATELLA 32MM 1943913 200-04-22 - CEMENTED FINNED TIB. TRA SZ 2F/2T 1551973 234-03-01 - OPTETRAK ASY,PS CEMENTED FEMORAL, SZ 1, 1731682 THESE DEVICES ARE USED FOR TREATMENT AND NOT DIAGNOSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, FRACTURE, AND TIBIAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2018 APPROXIMATELY 6 YEARS AND 2 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710933 PS TIBIAL INSERTS SZ 1, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862048158

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention