BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HIP

    MDR report key: 2071500 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-06659
    Event Type
    Injury
    Date Received
    April 15, 2011
    Report Date
    March 16, 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

    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 AFTER SURGERY, PATIENT SUFFERED SYMPTOMS AND DAMAGE TO HER BODY INCLUDING BUT NOT LIMITED TO SEVERE PAIN AND DISCOMFORT IN HER GROIN, THIGH, AND HIP; CLICKING, GRINDING AND POPPING OF THE IMPLANT WHEN SHE WALKED AND WENT TO AND FROM A SITING POSITION; INFECTION AND INFLAMMATION OF BONE AND TISSUE SURROUNDING THE IMPLANT; METALLOSIS; LACK OF MOBILITY; AND CHROMIUM AND COBALT METAL TOXICITY. IT IS FURTHER ALLEGED PATIENT WILL UNDERGO REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR HIP NONE KWA DEPUY INTERNATIONAL, LTD. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention