BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR FEMORAL HEAD

    MDR report key: 3223166 · Received July 12, 2013

    Report

    Report Number
    1818910-2013-21036
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    April 15, 2013
    Report Date
    November 10, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KXA
    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. (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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.(B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM HIGH CONCETRATIONS OF VARIOUS METALLIC ELEMENTS.

    Description of Event or Problem · 1

    UPDATE REC'D 11/10/2013 - MEDICAL RECORDS RECEIVED. UPON REVISION, BURSITIS, TURBID TISSUE FLUID, SYNOVITIS, AND FRETTING AND CORROSIVE CHANGES ON THE FEMORAL HEAD TAPER WERE NOTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: 06/04/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321616 UNKNOWN DEPUY ASR FEMORAL HEAD FEMORAL HEAD KXA DEPUY INTL., LTD. - 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention