BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP STB TB IN 4 10.0

    MDR report key: 1051125 · Received May 21, 2008

    Report

    Report Number
    1818910-2008-01562
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 21, 2008
    Manufacturer
    DEPUY - CORK, A DIV OF DEPUY ORTHOPAEDICS
    Product Code
    NJL
    PMA / PMN Number
    P830055
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE AS NO PROD WAS RETURNED. A SEARCH OF THE WARSAW AND INTL COMPLAINT DATABASE DID NOT FIND ANY ADD'L REPORTS OF THIS NATURE FOR THE PROD CODE/LOTS PROVIDED SINCE THEIR RESPECTIVE RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PROD CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PROD AND/OR ADD'L INFO BE REC'D TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED DUE TO KNEE PAIN (RIGHT SIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMARP STB TB IN 4 10.0 87NJL NJL DEPUY - CORK, A DIV OF DEPUY ORTHOPAEDICS NA 2222186

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention