BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 3230591 · Received July 16, 2013

    Report

    Report Number
    1818910-2013-21367
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    December 19, 2012
    Report Date
    July 11, 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
    OH, 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.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, ELEVATED CHROMIUM COBALT LEVELS, AND DIFFICULTY AMBULATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328060 UNKNOWN HIP FEMORAL HEAD FEMORAL HEAD KXA DEPUY INTL., LTD. - 8010379 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention