BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNIT FEMORAL IMPL SIZE 46

    MDR report key: 2052761 · Received April 7, 2011

    Report

    Report Number
    1818910-2011-05814
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    **UPDATE** 08/30/2012: LITIGATION DOCUMENTS WERE RECEIVED. LITIGATION ALLEGES THAT THE PATIENT SUFFERED PAIN AND DISABILITY. IN ADDITION, THE PATIENT HAS BEEN EXPOSED TO CHROMIUM AND COBALT AS A RESULT OF THE ASR IMPLANT AND HAS BEEN DAMAGED PHYSICALLY FROM SAID EXPOSURE. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    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. (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

    PT WAS REVISED TO ADDRESS ELEVATED METAL ION LEVELS AND METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNIT FEMORAL IMPL SIZE 46 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2697484

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention