BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN DELTA CER INSRT 58ODX36ID

    MDR report key: 2393958 · Received January 3, 2012

    Report

    Report Number
    1818910-2012-00031
    Event Type
    Injury
    Date Received
    January 3, 2012
    Date of Event
    March 27, 2011
    Report Date
    December 5, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    MRA
    PMA / PMN Number
    P070026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS CONFIRMED THAT NO PRODUCT WOULD BE RETURNED AND SO THE COMPLAINT WAS MOVED TO INVESTIGATION. A REVIEW OF THE MANUFACTURING RECORDS WAS CONDUCTED ON LOTS E32LB1000, 3202163 AND 3152209 WITH THE RESULT THAT NO ANOMALIES WERE FOUND. REVIEW OF OUR COMPLAINTS DATABASE FOR LOT NUMBERS E32LB1000, 3202163 AND 3152209 IDENTIFIED NO PREVIOUS COMPLAINTS FROM THESE BATCHES HAD BEEN RECEIVED. DUE TO NO SIMILAR FAILURES FOUND IN THE DHR REVIEW, THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. SHOULD FURTHER INFORMATION COME AVAILABLE THAT IMPACTS THE FINDINGS IN THIS INVESTIGATION IT WILL BE REOPENED. AS NO PRODUCT WAS RETURNED, NO FURTHER INVESTIGATION COULD TAKE PLACE. ROOT CAUSE: UNDETERMINED INSUFFICIENT INFORMATION 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

    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

    CERAMIC PRODUCT REVISED (B)(6) 2011 DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN DELTA CER INSRT 58ODX36ID HIP MRA DEPUY INTERNATIONAL 3202163

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention