BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 2151179 · Received June 30, 2011

    Report

    Report Number
    1818910-2011-11557
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    March 20, 2009
    Report Date
    May 31, 2011
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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 STILL CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PT CONTACTED BROADSPIRE TO INITIATE CLAIM. PT REPORTED REVISION SURGERY. REASON FOR REVISION IS UNK. NO FURTHER INFO IS AVAILABLE AT THIS TIME. UPDATE (B)(6) 2011 - LITIGATION PAPERS RECEIVED. THEY ALLEGE THAT PT WAS IMPLANTED WITH A DEPUY ASR HIP ON HER LEFT SIDE ON OR ABOUT (B)(6) 2008. AFTER HER IMPLANTATION, PT EXPERIENCED PAIN AND SUFFERING AND WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD. SHE WAS REVISED ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 45 TOTAL HIP REPLACEMENT KWA DEPUY INTL., LTD. NA 2485695

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention