BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 52

    MDR report key: 2254236 · Received September 19, 2011

    Report

    Report Number
    1818910-2011-18438
    Event Type
    Injury
    Date Received
    September 19, 2011
    Report Date
    August 22, 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
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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 PAPERS ALLEGE: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HER RIGHT SIDE ON OR ABOUT (B)(6) 2007. PATIENT HAS EXPERIENCED CONSTANT AND SEVERE PAIN AND DISCOMFORT IN HER THIGH, HIP-JOINT, AND GROIN; THE FORMATION OF METALLOSIS AND PSEUDOTUMORS, WHICH HAVE DAMAGED BONE AND TISSUE SURROUNDING THE IMPLANT; STIFFNESS; INFLAMMATION; CLICKING AND POPPING SENSATION IN HER HIP WHEN MOVING TO AND FROM A SITTING POSITION; INFECTION; CHROMIUM AND COBALT METAL TOXICITY; LACK OF MOBILITY; AND OTHER COMPLICATIONS. PATIENT WILL UNDERGO REVISION SURGERY IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 52 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2385346

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention