BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP STB TB IN 3 17.5

    MDR report key: 2112642 · Received May 19, 2011

    Report

    Report Number
    1818910-2011-08548
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    DEPUY-CORK, A DIV OF DEPUY ORTHOPAEDICS
    Product Code
    NJL
    PMA / PMN Number
    P835500/S113
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY ADDITIONAL REPORTS AGAINST THE PRODUCT LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED INFECTION. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS POSSIBLE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMARP STB TB IN 3 17.5 NJL DEPUY-CORK, A DIV OF DEPUY ORTHOPAEDICS NA 3232193

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention