BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 43

    MDR report key: 3110284 · Received May 13, 2013

    Report

    Report Number
    1818910-2013-03170
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    October 27, 2011
    Report Date
    January 26, 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 Location
    MO, US
    Reporter Occupation
    ATTORNEY

    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. REF. (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 PAPERS ALLEGE PAIN AND DISCOMFORT IN HER LEFT AND RIGHT HIPS CAUSING POTENTIAL UNNECESSARY AND ADDITIONAL SURGERIES, DIMINUTION IN EARNING CAPACITY, LOST WAGES, MEDICAL MONITORING EXPENSES, EMOTIONAL DISTRESS, LOSS OF ENJOYMENT OF LIFE, METALLOSIS EXPOSURE AND OTHER INJURIES PRESENTLY UNDIAGNOSED. UPDATE: (B)(4) 2012: PATIENT FACT SHEET FORM WAS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210873 ASR UNI FEMORAL IMPL SIZE 43 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL 2357070

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention