BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    KLASSIC FEMUR

    MDR report key: 24926382 · Received April 20, 2026

    Report

    Report Number
    3008544874-2026-00003
    Event Type
    Injury
    Date Received
    April 20, 2026
    Date of Event
    March 12, 2026
    Report Date
    April 17, 2026
    Manufacturer
    TOTAL JOINT ORTHOPEDICS, INC.
    Product Code
    JWH
    UDI-DI
    00814703016684
    PMA / PMN Number
    K153310
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO CORRECTION IS REQUIRED. THIS IS THE SECOND OCCURRENCE OF IMPLANT LOOSENING FOR A CR FEMUR (RGA 1771). THE OCCURRENCE OF IMPLANTS LOOSENING WILL CONTINUE TO BE MONITORED. THIS LOT OF FEMURS HAD A QUANTITY OF 52 AND ALL HAVE BEEN CONSUMED WITH NO OTHER REPORTS OF LOOSENING.

    Description of Event or Problem · 0

    PATIENT UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY DUE TO LOOSENING OF FEMORAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990591 KLASSIC FEMUR FEMORAL IMPLANT JWH TOTAL JOINT ORTHOPEDICS, INC. 55687 00814703016684

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention