BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX52OD

    MDR report key: 3141385 · Received June 3, 2013

    Report

    Report Number
    1818910-2013-18017
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    July 17, 2011
    Report Date
    May 10, 2013
    Manufacturer
    8010379 DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK083642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    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 AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. IT SHOULD BE NOTED, DISABILITIES OF OTHER JOINTS IS A KNOWN WARNING/PRECAUTION PER THE 0611-42-050 PINNACLE ACETABULAR CUP SYSTEM SURGICAL TECHNIQUE. THE CAUSE OF GRINDING CANNOT BE DETERMINED THROUGH THE X-RAY REVIEW. NO OBVIOUS PRODUCT PROBLEMS EVIDENT. CUP POSITIONING WAS MEASURED AT 55 DEGREES. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM (B)(6). CONFIRMED REVISION OF PINNACLE/CORAIL IMPLANTS. PATIENT SUFFERED WITH GRINDING AND INSTABILITY. BLOOD TESTS FOR METAL IONS CONFIRMED. OPERATIVE NOTES REVEAL MILD METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245184 PINNACLE MTL INS NEUT36IDX52OD METAL ACETABULAR INSERT KWA 8010379 DEPUY INTL., LTD. 3070358

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention