BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 58

    MDR report key: 3163619 · Received June 11, 2013

    Report

    Report Number
    1818910-2013-18641
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 31, 2013
    Report Date
    November 15, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS OF INFECTION AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. THE PATIENT WAS IMPLANTED IN (B)(6) 2007 AND REVISED IN (B)(6) 2013. IT IS NOT LIKELY THE DEVICE CONTRIBUTED TO THE PATIENTS REPORTED INFECTION SIX YEARS AFTER IMPLANTATION. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT REVISION PROCEDURE DUE TO INFECTION AND OSTEOLYSIS.

    Description of Event or Problem · 1

    **UPDATE**(B)(4) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN, METALLOSIS AND ADVERSE METAL REACTION. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263545 ASR ACETABULAR CUPS 58 ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 Y38GA1000

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention