BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 58

    MDR report key: 2971339 · Received February 21, 2013

    Report

    Report Number
    1818910-2013-03989
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    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

    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

    PATIENT WAS REVISED DUE TO PAIN, CLUNKING IN HIS HIP, ELEVATED METAL ION LEVELS, OSTEOLYSIS, SALES REP NOTED THAT THE CUP APPEARED TO HAVE MOVED FROM THE ORIGINAL POSITION BUT IT WAS NOT LOOSE AT THE TIME OF REVISION. UPDATE LITIGATION ALLEGED THE ASR HIP WAS EXPLANTED DUE TO PAIN, GRINDING, CLICKING, POPPING, DIFFICULTY WALKING, INFECTION, DISABILITY, DISFIGUREMENT AND ELEVATED BLOOD LEVELS OF CHROMIUM AND COBALT.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO PAIN, CLUNKING IN HIS HIP, ELEVATED METAL ION LEVELS, OSTEOLYSIS, SALES REP NOTED THAT THE CUP APPEARED TO HAVE MOVED FROM THE ORIGINAL POSITION BUT IT WAS NOT LOOSE AT THE TIME OF REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76410 ASR ACETABULAR CUPS 58 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2112731

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention