BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HEAD

    MDR report key: 2831996 · Received November 14, 2012

    Report

    Report Number
    1818910-2012-27726
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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).

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE PAIN. UPDATE LITIGATION ALLEGED THE ASR HIP WAS EXPLANTED DUE TO PAIN, ELEVATED COBALT AND CHROMIUM LEVELS AND METALLOSIS. THERE IS NO NEW INFORMATION THAT CHANGES THE OUTCOME OF THIS INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR HEAD FEMORAL HEAD KXA DEPUY INTERNATIONAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention