BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 2111543 · Received May 13, 2011

    Report

    Report Number
    1818910-2011-08563
    Event Type
    Injury
    Date Received
    May 13, 2011
    Report Date
    November 4, 2013
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. WWCAPA (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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2007, PT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HIS LEFT HIP. ON OR ABOUT (B)(6) 2008, PT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HIS RIGHT HIP. ON OR ABOUT (B)(6) 2009, PT BEGAN HAVING PAIN, WEAKNESS, SWELLING, SORENESS, AND NUMBNESS IN HIS HIP AREA, AS WELL AS LOCKING OF HIP COMPONENTS AND INCREASED METALLIC IONS IN HIS BLOODSTREAM. ADDITIONALLY IT IS ALLEGED THE PT WILL REQUIRE REVISION SURGERY OF THE LEFT AN RIGHT HIPS.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - SALES REP REPORTED REVISION SURGERY. REASON FOR REVISION UNKNOWN. SHOULD WE RECEIVE ADDITIONAL INFORMATION, WE WILL UPDATE AS NECESSARY. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. **UPDATE** (B)(4) 2013- PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOR FOR THE RIGHT HIP. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 50 ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL, LTD. NA 2718258

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention