BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 3081705 · Received April 29, 2013

    Report

    Report Number
    1818910-2013-01699
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    August 31, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. REF. (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. NOT RECEIVED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HER RIGHT SIDE ON OR ABOUT (B)(6) 2007, AND ON HER LEFT SIDE ON OR ABOUT (B)(6) 2009. PATIENT HAS EXPERIENCED PAIN AND ELEVATED LEVELS OF COBALT AND CHROMIUM. PATIENT HAS NOT YET SCHEDULED REVISION SURGERIES FOR EITHER SIDE. UPDATE: (B)(6) 2011. PLAINTIFFS PRELIMINARY DISCLOSURE (PPD) FORM RECEIVED (B)(6) 2011. CHANGED 2 UNK ASR HIPS TO ASR CUP HEAD AND ADDED ASR CUP FEMORAL HEAD PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185666 ASR ACETABULAR CUPS 54 ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL 2710385

    Patients

    Seq Age Sex Outcome Treatment
    1 Other