BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER FEMORAL HEAD

    MDR report key: 5261916 · Received December 2, 2015

    Report

    Report Number
    1822565-2015-02497
    Event Type
    Injury
    Date Received
    December 2, 2015
    Report Date
    November 5, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    KWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING AMENDED TO REFLECT CHANGES IN SECTIONS. OTHER DEVICE USED: CATALOG #00652805000, HGP ACETABULAR CUP, #(B)(4) ; CATALOG #UNK, UNKNOWN ZIMMER HG LINER, LOT #UNK THE DEVICES WERE NOT RETURNED; THEREFORE THEIR SPECIFIC CONDITION IS UNKNOWN. DEVICE HISTORY RECORD REVIEW FOR THE ACETABULAR CUP FOUND THAT THE DEVICES WERE MANUFACTURED, INSPECTED, STERILIZED AND PACKAGED IN ACCORDANCE TO QUALITY PROCEDURES AT THE TIME OF MANUFACTURE. A COMPLAINT HISTORY SEARCH FOR THIS HGP CUP FOUND NO OTHER COMPLAINTS FOR THIS PART/LOT COMBINATION. WITH THE INFORMATION RECEIVED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH CERTAINTY AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. THE PATIENT ALSO BELIEVES HER BODY ABSORBED THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790076 UNKNOWN ZIMMER FEMORAL HEAD HIP PROSTHESIS KWZ ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention