BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FEMORAL HEAD

    MDR report key: 6835357 · Received August 31, 2017

    Report

    Report Number
    0001822565-2017-06242
    Event Type
    Injury
    Date Received
    August 31, 2017
    Date of Event
    January 11, 2013
    Report Date
    August 31, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    MEH
    PMA / PMN Number
    PNI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FEMORAL STEM 15MM, CATALOG#:00663001500, LOT#:43534500; UNKNOWN FEMORAL HEAD, CATALOG#: UNKNOWN, LOT#: UNKNOWN. DEVICE WAS NOT RETURNED SO NO PRODUCT EVALUATION COULD BE CONDUCTED. THIS DEVICE WAS USED FOR TREATMENT. DEVICE HISTORY REPORT WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2016-02236-2.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT WAS REVISED DUE TO METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614048 UNKNOWN FEMORAL HEAD HIP PROSTHESIS MEH ZIMMER, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| O