BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 2993313 · Received March 7, 2013

    Report

    Report Number
    1818910-2013-02962
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 28, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD INCREASING PAIN WHICH SIGNIFICANTLY IMPAIRED ABILITY TO PERFORM DAILY ACTIVITIES AND SLEEP; INCREASED BLOOD METAL ION LEVELS; AND MRI SHOWING SOFT TISSUE MASS CONSISTENT WITH A PSEUDOTUMOR ON RIGHT HIP AND A COLLECTION OF FLUID ON LEFT HIP AFTER ASR HIP IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98156 ASR ACETABULAR CUPS 50 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2458298

    Patients

    Seq Age Sex Outcome Treatment
    1 Other