BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY

    MDR report key: 1823546 · Received August 27, 2010

    Report

    Report Number
    MW5017283
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 27, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A TOTAL HIP REPLACEMENT -RIGHT SIDE- IN (B)(6) 2005. I HAVE HAD THREE HIP REPLACEMENT DISLOCATIONS SINCE THEN. THE LAST ONE WAS (B)(6) 2010. I WENT TO MY DOCTOR -DR. (B)(6), (B)(6) MEDICAL CENTER, (B)(6)- THAT DID THE HIP REPLACEMENT TO SEE WHAT THE PROBLEM COULD BE. HE TOOK X-RAYS AND SAID EVERYTHING LOOKED GOOD AND THAT THERE WAS NOTHING TO FIX. LAST NIGHT I HEARD ON THE NEWS THAT THERE IS A DEPUY HIP REPLACEMENT RECALL. I PULLED MY HIP REPLACEMENT PAPERWORK AND THE INFORMATION ON MY PARTS ARE LISTED DEPUY: DEPUY PINNACLE SECTOR ACETABULAR CUP SZ MM 50 REF: 1217-22-050, LOT# ZF2CD1000 DEPUY PINNACLE CANCELLOUS BONE SCREW DIA MM 6.5 MM LGT 35, DEPUY MARATHON ACETABULAR LINER NEUT LNR ANG 50 MM 0D 28 MM, (B)(4) V40TM ALUMINA FEMORAL HEAD -2.7MM 28MM CASE (B)(4). THIS, IN MY OPINION, SHOULD NOT BE HAPPENING. THE FIRST TIME I WAS BENDING FORWARD LEANING TO THE RIGHT, THE SECOND TIME I WENT TO SIT DOWN ON THE SOFA, THE THIRD TIME I WAS SITTING IN A CHAIR AND WAS IN A CURLED POSITION AND WENT TO STRAIGHTEN OUT ON THE OTTOMAN. IT'S POPPING OUT TOO EASILY. THIS SHOULD NOT BE HAPPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY PINNACLE SECTOR, PINNACLE, PINNACLE MARATHON, ACETABULAR CUP SZ MM 50 KWA DEPUY ORTHOPAEDICS, INC. ZF2CD1000
    2 DEPUY PINNACLE CANCELLOUS BONE SCREW, DIA MM KWA DEPUY ORTHOPAEDICS, INC. Y5RJC4000
    3 ACETABULAR LINER HOW/OST ACETABULAR LINER HOW/OST KWA DEPUY ORTHOPAEDICS, INC.
    4 V40 ALUM PINNACLE CANCELLOUS BONE SCREW KWA DEPUY ORTHOPAEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR