BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 58

    MDR report key: 2243477 · Received September 12, 2011

    Report

    Report Number
    1818910-2011-17456
    Event Type
    Injury
    Date Received
    September 12, 2011
    Report Date
    August 15, 2011
    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
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    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

    LITIGATION PAPERS ALLEGE: IN (B)(6) 2006, PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP. IN (B)(6) 2008, PATIENT BEGAN EXPERIENCING SYMPTOMS, SUCH AS DISCOMFORT, SQUEAKING, PAIN, AND SORENESS, WHICH IN TURN NEGATIVELY AFFECTED HER ABILITY TO WALK, MOVE, AND SLEEP. ADDITIONALLY, IT IS ALLEGED THAT METAL ON METAL ABRASION PUT PATIENT AT RISK FOR METALLOSIS, DUE TO METAL PARTICLES REMAINING IN HER BODY. IN DECEMBER 2008, PATIENT UNDERWENT REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 58 ACETABULAR CUP KWA DEPUY INTERNATIONAL 1981368

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention