BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 2840978 · Received November 20, 2012

    Report

    Report Number
    1818910-2012-26874
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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. Z-1749/1816-2011.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO PAIN. (RIGHT HIP).

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO PAIN. UPDATE LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, PERMANENT INJURIES AND EXPOSURE TO TOXIC LEVELS OF CHROMIUM AND COBALT AS A RESULT OF THE IMPLANTED ASR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 47 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2399997

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention