BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 60

    MDR report key: 2240520 · Received September 9, 2011

    Report

    Report Number
    1818910-2011-17707
    Event Type
    Injury
    Date Received
    September 9, 2011
    Report Date
    August 11, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. (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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT HAS SUFFERED SEVERE PAIN, CRUNCHING OR POPPING IN THEIR HIP REGION, DIFFICULTY STANDING OR WALKING, HIP FRACTURES OR DISLOCATIONS, FATIGUE, TISSUE INFLAMMATION, INFECTION, NECROSIS AND METALLOSIS. IF IS FURTHER ALLEGED PATIENT HAS ENDURED, OR WILL ENDURE, UNNECESSARY PAIN AND SUFFERING; DEBILITATING LACK OF MOBILITY; INFLAMMATION CAUSING DAMAGE OR DEATH TO SURROUNDING BONE AND TISSUE; MORE DIFFICULT REVISION SURGERIES; SHORTENED LIFE OF SUBSEQUENT IMPLANTS; PROLONGED RECOVERY TIME; PHYSICAL THERAPY; LOST WAGES; AND AN INCREASED RISK OF COMPLICATIONS AND/OR DEATH FROM ADDITIONAL REVISION SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 60 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2346794

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention