BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 43

    MDR report key: 2211795 · Received August 10, 2011

    Report

    Report Number
    1818910-2011-15403
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    January 31, 2011
    Report Date
    June 23, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    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 (B)(6) 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 INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HER RIGHT SIDE ON OR ABOUT (B)(6), 2008. PT EXPERIENCED PHYSICAL INJURY AND BODILY IMPAIRMENT; DEBILITATING LACK OF MOBILITY; AND PAIN. PT HAD THE DEPUY ASR HIP IMPLANT EXPLANTED ON (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 43 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2493325

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention