BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP CV TB/IN S3 15.0

    MDR report key: 1031825 · Received April 18, 2008

    Report

    Report Number
    1818910-2008-01398
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 1, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, DEPUY-CORK
    Product Code
    NJL
    PMA / PMN Number
    PMA077
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 STATED THE PRODUCT WAS NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED INSTABILITY; HOWEVER, PROVIDED INFO INDICATES THE SIZE DEVICE INSERTED AT PRIMARY SURGERY DID NOT ACHIEVE THE DESIRED RESULTS. 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 ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED TO CORRECT INSERT THAT WAS IMPLANTED EARLIER SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMARP CV TB/IN S3 15.0 87NJL NJL DEPUY ORTHOPAEDICS, DEPUY-CORK NA 2545894

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention