BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 62

    MDR report key: 2122644 · Received June 3, 2011

    Report

    Report Number
    1818910-2011-10023
    Event Type
    Injury
    Date Received
    June 3, 2011
    Report Date
    May 5, 2011
    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
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON HIS LEFT SIDE, ON OR ABOUT (B)(6), 2007. FOLLOWING HIS ORIGINAL HIP REPLACEMENT SURGERY, PATIENT BEGAN TO EXPERIENCE PAIN IN THE AREA OF HIS HIP REPLACEMENT, AS WELL AS DIFFICULTY IN AMBULATION. PATIENT HAS BEEN ADVISED THAT THE PROSTHESIS SHOULD BE REMOVED AND REPLACED. (B)(6) 2011 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED DUE TO STIFFNESS AND PAIN. THE REPORT STATED THAT PATIENT HAD LOW COBALT AND CHROMIUM LEVELS.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON HIS LEFT SIDE, ON OR ABOUT (B)(6) 2007. FOLLOWING HIS ORIGINAL HIP REPLACEMENT SURGERY, PATIENT BEGAN TO EXPERIENCE PAIN IN THE AREA OF HIS HIP REPLACEMENT, AS WELL AS DIFFICULTY IN AMBULATION. PATIENT HAS BEEN ADVISED THAT THE PROSTHESIS SHOULD BE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 62 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD. NA 2141311

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention