BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HIP

    MDR report key: 2121886 · Received June 9, 2011

    Report

    Report Number
    1818910-2011-09940
    Event Type
    Injury
    Date Received
    June 9, 2011
    Report Date
    May 10, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    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

    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

    LITIGATION PAPERS ALLEGE THE FOLLOWING: ON OR ABOUT (B)(6), 2009, PT WAS IMPLANTED WITH COMPONENTS OF THE ASR SYSTEM INTO THE RIGHT HIP. FOLLOWING EACH SURGERY, PT'S WOUNDS HEALED WITHOUT INFECTION, X-RAYS SHOWED THE ASR SYSTEM COMPONENTS TO BE, INITIALLY, PROPERLY POSITIONED AND AFFIXED, AND THE PROSTHESES SUFFERED NO UNEXPECTED IMPACTS. PT WILL REQUIRE A HIP REPLACEMENT SURGERY AS A RESULT OF COMPLICATIONS CAUSED BY THE EFFECTIVE ASR IMPLANT. SHE IS CURRENTLY MAKING ARRANGEMENTS WITH HER ORTHOPEDIC SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR HIP TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention