BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2900660 · Received January 7, 2013

    Report

    Report Number
    1818910-2013-00276
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    January 25, 2011
    Report Date
    August 24, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    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). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERED INCREASINGLY DEBILITATING PAIN, DISCOMFORT, SORENESS, AS WELL AS A CATCHING SENSATION, WHICH IN TURN AFFECTED THE PATIENTS ABILITY TO WALK, MOVE AND SLEEP. DURING THE REVISION SURGERY, HER ACETABULAR SHELL WAS FOUND TO HAVE ESSENTIALLY NO BONY INGROWTH AT ALL. THE PATIENT ALSO HAD EXCESSIVE LEVELS OF CHROMIUM AND COBALT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7068 ASR UNI FEMORAL IMPL SIZE 46 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL 2425208

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention