BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 43

    MDR report key: 2862199 · Received December 7, 2012

    Report

    Report Number
    1818910-2012-27222
    Event Type
    Injury
    Date Received
    December 7, 2012
    Report Date
    August 23, 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
    MO, 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

    LEGAL CLAIM RECEIVED. THERE IS NO MENTION OF WHY A REVISION WOULD BE NECESSARY, HOWEVER, IT HAS BEEN INDICATED THAT PATIENT WAS REVISED. NO FURTHER INFORMATION AVAILABLE AT THIS TIME. **UPDATE** (B)(6) 2012 - PATIENT FACT SHEET WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION, BIRTHDATE, AND DOI. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. **UPDATE** (B)(6) 2012 - LITIGATION RECEIVED (B)(6) 2012. LITIGATION ALLEGES PATIENT SUFFERED PAIN, DIFFICULTY AMBULATING, MUSCLE LOSS, TISSUE DESTRUCTION, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 43 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2248169

    Patients

    Seq Age Sex Outcome Treatment
    1 Other