BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M/H 3HOLE RLC SHL NRS 54MM/L24

    MDR report key: 7746761 · Received August 3, 2018

    Report

    Report Number
    0001825034-2018-05308
    Event Type
    Injury
    Date Received
    August 3, 2018
    Date of Event
    October 19, 2011
    Report Date
    July 31, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK921181
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. CONCOMITANT PRODUCTS: ITEM # 14-103204, STEM, LOT # UNK; ITEM # 12-115120, HEAD, LOT # UNK; ITEM # UNK, LINER, LOT # UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 3 YEARS POST IMPLANTATION, THE PATIENT RECEIVED AN ILIOPSOAS INJECTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589785 M/H 3HOLE RLC SHL NRS 54MM/L24 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention