BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR300 ACETABULAR SIZE 56MM

    MDR report key: 1990017 · Received February 9, 2011

    Report

    Report Number
    MW5019385
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 9, 2011
    Manufacturer
    DEPUY
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF DEPUY ASR 300 ACETABULAR COMPONENT WITH HEAD COMPONENT AND SLEEVE COMPONENT IMPLANTED ON (B)(6) 2009. EXPLANTED ON (B)(6) 2011 DUE TO DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR300 ACETABULAR SIZE 56MM ARTIFICIAL HIP KWA DEPUY DEPUY ASR300 2833742
    2 DEPUY ASR UNIFEMORAL SIZE 49 ARTIFICIAL HIP KWA DEPUY DEPUY ASR300 2774558

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| S