BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 2923938 · Received January 22, 2013

    Report

    Report Number
    1818910-2013-00331
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    April 9, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. REF. (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

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT FOLLOWING THE IMPLANTATION SURGERY, THE PATIENT SUFFERED PAIN, DIFFICULTY AMBULATING, MUSCLE LOSS, TISSUE DESTRUCTION AND WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29152 ASR UNI FEMORAL IMPL SIZE 51 FEMORAL HEAD HIP IMPLANT KXA DEPUY INTERNATIONAL 2178596

    Patients

    Seq Age Sex Outcome Treatment
    1 Other