BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR FEMORAL HEAD

    MDR report key: 2855219 · Received December 3, 2012

    Report

    Report Number
    1818910-2012-25459
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 16, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. NOT RECEIVED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED PAIN IN HER RIGHT HIP, POPPING SENSATION, LOOSENED ACETABULAR COMPONENTS, OSTEOLYSIS, METALLOSIS, NEED FOR REVISION SURGERIES OF HER RIGHT HIP, AND OTHER INJURIES DUE TO DEFECTS IN HER HIP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR FEMORAL HEAD FEMORAL HEAD HIP IMPLANT KXA DEPUY INTERNATIONAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other