BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HEAD

    MDR report key: 2121931 · Received June 9, 2011

    Report

    Report Number
    1818910-2011-10064
    Event Type
    Injury
    Date Received
    June 9, 2011
    Report Date
    May 10, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    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

    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 CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME.

    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. (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: ON (B)(6) 2006 AND (B)(6) 2008, PT UNDERWENT SURGICAL PROCEDURES TO IMPLANT DEPUY ASR HIP IMPLANTS. IN THE YEARS FOLLOWING HER SURGERY, PT EXPERIENCED DISCOMFORT AND PAIN IN HER HIPS, GROIN, AND LEG. IT BECAME INCREASINGLY PAINFUL FOR HER TO WALK, TO MOVE HER LEGS, AND TO RISE FROM A SEATED POSITION. ON (B)(6) 2011, PT UNDERWENT A REVISION SURGERY TO REPLACE HER IMPLANT. SHE WILL ALLEGEDLY UNDERGO A SECOND REVISION SURGERY ON THE OTHER HIP IN 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR HEAD FEMORAL HEAD KWA DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention