BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP CVTBIN S2.5 10.0

    MDR report key: 1243033 · Received November 21, 2008

    Report

    Report Number
    1818910-2008-05259
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 29, 2008
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    NJL
    PMA / PMN Number
    P830055/S077
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT REVEAL ANY OTHER REPORTS AGAINST THE MFG LOT. THE INITIAL REPORTING INDICATED THE PRODUCT WAS NOT SUSPECTED OF FAILING TO MEET SPECS OR CONTRIBUTING TO THE EVENT. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED PAIN AND GRINDING. PROVIDED INFO SUGGESTS PT SCAR TISSUE WAS A POSSIBLE CONTRIBUTING FACTOR. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF PAIN AND "GRINDING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMARP CVTBIN S2.5 10.0 87NJL NJL DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 2656011

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention