BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR TAPER SLEEVE ADAPTOR

    MDR report key: 2931710 · Received January 28, 2013

    Report

    Report Number
    1818910-2013-01246
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    August 8, 2012
    Report Date
    May 31, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE: (B)(6) 2013 - PPD RECEIVED. PART/LOT INFORMATION HAS BEEN UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY CONSIDERS THIS COMPLAINT CLOSED AT THIS TIME.

    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).

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND OSTEOLYSIS. UPDATE LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, SWELLING, INFLAMMATION, METALLOSIS, INFECTION, DAMAGE TO SURROUNDING BONES AND TISSUES, DECREASED MOBILITY AND EXPOSURE TO EXCESSIVE LEVELS OF CHROMIUM AND COBALT AS A RESULT OF THE IMPLANTED ASR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36376 DEPUY ASR TAPER SLEEVE ADAPTOR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2071787

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention