BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    KLASSIC FEMUR

    MDR report key: 20303275 · Received September 25, 2024

    Report

    Report Number
    3008544874-2022-00001
    Event Type
    Injury
    Date Received
    September 25, 2024
    Date of Event
    August 27, 2024
    Report Date
    September 24, 2024
    Manufacturer
    TOTAL JOINT ORTHOPEDICS, INC.
    Product Code
    JWH
    UDI-DI
    00814703016653
    PMA / PMN Number
    K153310
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER INSPECTION OF THE RETURNED IMPLANT AND REVIEW OF MANUFACTURING RECORDS WE WERE UNABLE TO DETERMINE THE CAUSE OF IMPLANT LOOSENING. IMPLANT RECORDS SHOW THAT THIS LOT OF FEMURS WAS MADE TO SPECIFICATION. NO OTHER COMPLAINTS HAVE BEEN REPORTED REGARDING THIS IMPLANT. THIS LOT OF FEMURS HAD A QUANTITY OF (B)(4) 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
    2263100 KLASSIC FEMUR FEMORAL IMPLANT JWH TOTAL JOINT ORTHOPEDICS, INC. C1322023 00814703016653

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention