BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 53

    MDR report key: 3140772 · Received May 31, 2013

    Report

    Report Number
    1818910-2013-05508
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    January 11, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    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. 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE BILATERAL PATIENT WAS REVISED ON THE RIGHT SIDE AND HAS AN ASR IMPLANT ON THE LEFT SIDE ALSO. UPDATE THE PATIENTS LEFT SIDE WAS REVISED ON 2/28/2011 TO ADDRESS PAIN AND TISSUE THAT HAD THE APPEARANCE OF CREAM OF MUSHROOM SOUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241985 ASR UNI FEMORAL IMPL SIZE 53 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2415843

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention