BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 55

    MDR report key: 2912327 · Received January 11, 2013

    Report

    Report Number
    1818910-2013-00239
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 11, 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
    MN, 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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE ASR HIP IMPLANT WAS EXPLANTED DUE TO PAIN, INSTABILITY OF THE IMPLANTED DEVICE, METALLOSIS, SWELLING, BURSITIS, LACK OF MOBILITY AND EXPOSURE TO EXCESSIVE LEVELS OF CHROMIUM AND COBALT.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE ASR HIP IMPLANT WAS EXPLANTED DUE TO PAIN, INSTABILITY OF THE IMPLANTED DEVICE, METALLOSIS, SWELLING, BURSITIS, LACK OF MOBILITY AND EXPOSURE TO EXCESSIVE LEVELS OF CHROMIUM AND COBALT. **UPDATE**(B)(6) 2013 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. 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
    18998 ASR UNI FEMORAL IMPL SIZE 55 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2300295

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention