BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 19315357 · Received May 14, 2024

    Report

    Report Number
    1038671-2024-01247
    Event Type
    Injury
    Date Received
    May 14, 2024
    Date of Event
    April 28, 2023
    Report Date
    February 26, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862159274
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 2579780 (B)(6) - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 2.5T 2600527 (B)(6) - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 2.5T 2654467 (B)(6) - LOGIC CR FEMORAL CEM, LEFT, SZ 3.5 2654492 (B)(6) - LOGIC CR FEMORAL CEM, RIGHT, SZ 3.5 2712866 (B)(6) - ONE PEG PATELLA 32MM 2712871 (B)(6) - ONE PEG PATELLA 32MM. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO PHOTOGRAPHS OR X-RAYS WERE PROVIDED FOR REVIEW; THEREFORE THE REPORTED EVENT CANNOT BE CONFIRMED THROUGH ANALYSIS. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED BASED ON THE INFORMATION MADE AVAILABLE. SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    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 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. 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 THAT APPROXIMATELY 118 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, SWELLING, STIFFNESS, OSTEOLYSIS AROUND THE PROXIMAL TIBIA, SYNOVITIS, ABNORMAL WEAR OF THE TIBIAL INSERT ON THE MEDIAL SIDE AND OXIDATION OF THE LATERAL SIDE, AND DELAMINATION OF THE PATELLA. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548601 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862159274

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention| H SEE H10