BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIG RPF CEM FEM SZ 5 RT

    MDR report key: 2121379 · Received June 1, 2011

    Report

    Report Number
    1818910-2011-08619
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    April 4, 2011
    Report Date
    May 6, 2011
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS
    Product Code
    NJL
    PMA / PMN Number
    P830055/S110
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. THE RETAINED SAMPLES WERE CONDITIONED AND TESTED AT AN AMBIENT TEMPERATURE OF 23 DEG C. ALL HANDLING AND MECHANICAL STRENGTH RESULTS WERE REVIEWED AND THEY ARE ALL WITHIN SPECIFICATION. A REVIEW OF DEVICE HISTORY RECORDS FINDS NO MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE EVENT. A REVIEW OF MICRO AND STERILITY TESTS FINDS NO DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE EVENT. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. 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

    THE SURGEON CLAIMS THAT THE CEMENT USED DID NOT PERFECTLY ADHERE WITH THE IMPLANT DEVICES. IT RATHER REMAINED STUCK ON THE DEVICES THEMSELVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIG RPF CEM FEM SZ 5 RT 87 NJL NJL DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS NA CF1GJ4000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention