BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 53

    MDR report key: 2220209 · Received August 15, 2011

    Report

    Report Number
    1818910-2011-14584
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    March 19, 2007
    Report Date
    June 24, 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
    VA, 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

    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 THE PT WAS REVISED DUE TO RECURRENT DISLOCATIONS, THE PT'S ASR CUP AND HEAD WERE REPLACED WITH A NEW ASR CUP AND HEAD ON OR ABOUT (B)(6), 2007. IT IS FURTHER ALLEGED THE PT EXPERIENCED COBALT AND/OR CHROMIUM POISONING, PAIN, CRACKING AND POPPING IN THE LEFT HIP; CONSTANT PAIN, INABILITY TO LEAD A NORMAL LIFE, NUMEROUS F/U DOCTOR VISITS, ANXIETY, FEAR AND MENTAL ANGUISH AND OTHER EMOTIONAL AND PHYSICAL DAMAGES. THE PT UNDERWENT EXPLANT SURGERY ON HIS LEFT HIP ON OR ABOUT (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 53 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2209300

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention