BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 2934473 · Received January 30, 2013

    Report

    Report Number
    1818910-2013-02030
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    June 19, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4).

    Description of Event or Problem · 1

    UPDATE: (B)(4) 2013 - SALES REP REPORTED REVISION OF RIGHT HIP.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN, WEAKNESS, DIFFICULTY WITH SIMPLE DAILY LIVING ACTIVITIES, LEG LENGTH INEQUALITY AND INCREASED METALLIC IONS IN BLOODSTREAM AFTER ASR HIP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39952 ASR ACETABULAR CUPS 54 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2876237

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R