BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR FEMORAL HEAD

    MDR report key: 2244041 · Received September 12, 2011

    Report

    Report Number
    1818910-2011-17782
    Event Type
    Injury
    Date Received
    September 12, 2011
    Report Date
    August 15, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWY
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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: IN (B)(6) 2003 PATIENT UNDERWENT A SURGICAL PROCEDURE TO IMPLANT AN ASR HIP. IN APPROXIMATELY (B)(6) 2008, PATIENT BEGAN EXPERIENCING SYMPTOMS INCLUDING, BUT NOT LIMITED TO, DISCOMFORT, SQUEAKING, PAIN, AND SORENESS, WHICH IN TURN NEGATIVELY AFFECTED HER ABILITY TO WALK, MOVE, AND SLEEP. PATIENTS SURGEON INVESTIGATED HER SYMPTOMS AND IN APPROXIMATELY (B)(6) 2010, CONCLUDED THAT THE PROBLEMS WERE STEMMING FROM THE ASR HIP, AND THAT PATIENT WAS GOING TO HAVE TO UNDERGO REVISION SURGERY. IN (B)(6) 2011, PATIENT UNDERWENT REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR FEMORAL HEAD FEMORAL HEAD KWY DEPUY INTERNATIONAL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention