BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY AS ACETABULAR CUP

    MDR report key: 2781635 · Received October 10, 2012

    Report

    Report Number
    1818910-2012-75987
    Event Type
    Injury
    Date Received
    October 10, 2012
    Report Date
    August 21, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, DISCOMFORT, ELEVATED LEVELS OF CHROMIUM AND COBALT, DECREASED MOBILITY, PSEUDOTUMORS, DAMAGE TO SURROUNDING BONE AND TISSUE, STIFFNESS, INFLAMMATION, A POPPING OR CLICKING SENSATION WITHIN THE JOINT SPACE AND METAL TOXICITY AS A RESULT OF THE IMPLANTED ASR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY AS ACETABULAR CUP ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other