BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASR

    MDR report key: 2111546 · Received May 31, 2011

    Report

    Report Number
    2111546
    Event Type
    Malfunction
    Date Received
    May 31, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 31, 2011
    Manufacturer
    DEPUY
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FEMALE PT WHO HAD A RIGHT TOTAL HIP ARTHROPLASTY WITH ASR AND THERE WAS CONCERN OF SOME METALLOSIS AND PROBLEMS STEMMING FROM HER HIP. PRE/POSTOPERATIVE DIAGNOSIS WAS "FAILED RIGHT TOTAL HIP ARTHROPLASTY ASR CUP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABUL KWA DEPUY DP9998902470 2584910

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR NO OTHER THERAPIES| NONE KNOWN