BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTILOCK FEMORAL STEM

    MDR report key: 5761071 · Received June 30, 2016

    Report

    Report Number
    0001822565-2016-02236
    Event Type
    Injury
    Date Received
    June 30, 2016
    Date of Event
    January 11, 2013
    Report Date
    August 31, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK921308
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING AMENDED TO REFLECT CHANGES IN BRAND NAME, COMMON DEVICE NAME, MODEL/LOT #, IMPLANT DATE, DATE RECEIVED BY MFR, TYPE OF REPORTS, IF FOLLOW-UP, WHAT TYPE?, DEVICE MANUFACTURE DATE, AND ADDITIONAL MFR NARRATIVE. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. FEMORAL STEM 15 MM, 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. DHR 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, 0001822565-2017-06242.

    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
    416071 MULTILOCK FEMORAL STEM HIP PROSTHESIS JDI ZIMMER, INC. N/A 43534500

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| O