BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR FEMORAL HEAD

    MDR report key: 2854553 · Received December 3, 2012

    Report

    Report Number
    1818910-2012-24230
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    July 1, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. REF. (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. (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATE: (B)(6) 2013 - ASR/SUPPLEMENTAL INFORMATION RECEIVED. DOR AND DOB HAVE BEEN UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY CONSIDERS THIS COMPLAINT CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT SOMETIME AFTER IMPLANTATION, THE PATIENT WAS ADVISED THAT HER IMPLANT WAS FAILING AND THAT SHE HAD HIGH CONCENTRATIONS OF VARIOUS METALLIC ELEMENTS IN HER BLOOD. ADDITIONALLY, THE LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED INJURIES OF A PERMANENT NATURE; ENDURED PAIN AND SUFFERING AND IS UNABLE TO ATTEND TO HER NORMAL AFFAIRS AND DUTIES FOR AN INDEFINITE PERIOD OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR FEMORAL HEAD FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other