BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY

    MDR report key: 1823523 · Received August 29, 2010

    Report

    Report Number
    MW5017275
    Event Type
    Injury
    Date Received
    August 29, 2010
    Date of Event
    October 1, 2008
    Report Date
    August 29, 2010
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I HAD HIP REVISION SURGERY (B)(6) 2008 USING DEPUY PARTS. I EXPERIENCED A LOT OF PAIN FOR MONTHS THEN A CT SHOWED FRACTURES OF PELVIS AND LOWER BACK. I HAD ANOTHER REVISION SURGERY (B)(6) 2009 WHICH HAS BEEN SUCCESSFUL USING A ZIMMER IMPLANT. THE PINNACLE SYSTEM WAS USED IN THE FAILED HIP SURGERY. I DO NOT KNOW WHAT FAILED, THE SURGEON, THE PARTS OR ME. BUT IT IS IMPORTANT TO COLLECT DATA ON FAILED MEDICAL DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY HIP IMPLANTS JDI CP7GR1000
    2 DEPUY ACETABULAR LINER JDI B43BS1000
    3 DEPUY FEMORAL HEAD KWY B2467437
    4 DEPUY HOLE ELIMANATOR JDI B12AN1000
    5 DEPUY CANC. BONE SCREW HWC A36CY4000
    6 DEPUY CANC. BONE SCREW HWC Y3GN44000

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention| S