BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP CV TB/IN S3 12.5

    MDR report key: 3031110 · Received April 2, 2013

    Report

    Report Number
    1818910-2013-14780
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    DEPUY IRELAND ? REG. # 9616671
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. SURGICAL INTERVENTION DUE TO INSTABILITY, DURING THE ORIGINAL SURGERY THE WRONG INSERT WAS PUT IN THE PATIENT WHICH IS NOW BEING REVISED FOR INSTABILITY.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THE ROOT CAUSE IS ATTRIBUTED TO USER ERROR. THE INVESTIGATION DID NOT FIND ANY EVIDENCE OF PRODUCT ERROR AS 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 INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE WRONG TIBIAL INSERT WAS IMPLANTED. A CR INSERT WAS IMPLANTED, WHEN IT SHOULD HAVE BEEN A PS INSERT. UPDATE: (B)(6) 2013. SALES REP REPORTS THAT THE PATIENT WAS REVISED BECAUSE OF INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133518 PFC SIGMARP CV TB/IN S3 12.5 KNEE REPLACEMENT NJL DEPUY IRELAND ? REG. # 9616671 2960803

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention