BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR FEM IMPLANT SZ 49

    MDR report key: 2923940 · Received January 22, 2013

    Report

    Report Number
    1818910-2013-02175
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    February 16, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KXA
    PMA / PMN Number
    K032659
    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

    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.

    Description of Event or Problem · 1

    BILATERAL PATIENT. LITIGATION ALLEGES THAT THE ACETABULAR CUP EVENTUALLY DETACHED, DISCONNECTED, CREATED METALLIC DEBRIS, AND/OR LOOSENED FROM PATIENTS ACETABULUM, CAUSED SEVERE PAIN, INHIBITED PATIENTS ABILITY TO WALK, AND WILL LIKELY REQUIRE A REVISION SURGERY. **UPDATE** (B)(4) 2012 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION AND IMPLANT DATES. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30501 DEPUY ASR FEM IMPLANT SZ 49 FEMORAL HEAD KXA DEPUY INTERNATIONAL 2319271

    Patients

    Seq Age Sex Outcome Treatment
    1 Other