BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 3081225 · Received April 26, 2013

    Report

    Report Number
    1818910-2013-01698
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    October 9, 2012
    Report Date
    January 24, 2012
    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. NOT RECEIVED.

    Description of Event or Problem · 1

    BILATERAL PATIENT: LITIGATION PAPERS ALLEGE NEED FOR ADDITIONAL SURGERY, EXCESSIVE LEVELS OF COBALT AND CHROMIUM IN SERUM BLOOD, AND PAST AND FUTURE PAIN AND SUFFERING. **UPDATE**(B)(6) 2012 -SALES REP REPORTED REVISION SURGERY ON 10/09/2012 FOR THE LEFT HIP DUE TO POSITIONING OF THE CUP WAS VERTICAL. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. ***UPDATE*** (B)(6) 2012 PLAINTIFF'S PRELIMINARY DISCLOSURE (PPD) FORM RECEIVED (B)(6) 2012. ADDED LEFT FEMORAL HEAD PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182379 ASR UNI FEMORAL IMPL SIZE 51 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2739322

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention