BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TC3 RP TIBIAL INSERT S5, 10.0

    MDR report key: 1003969 · Received February 22, 2008

    Report

    Report Number
    1818910-2008-00394
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 25, 2008
    Report Date
    January 25, 2008
    Manufacturer
    DEPUY - RAYNHAM A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    PMA084
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROD WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE DID NOT REVEAL ANY OTHER REPORTS FOR THE MFG LOT. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED INFECTION. NO EVIDENCE WAS FOUND SUGGESTING PROD ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADD'L INFO BE REC'D, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED TO ADDRESS INFECTION, DID A POLY SWAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TC3 RP TIBIAL INSERT S5, 10.0 87NJL NJL DEPUY - RAYNHAM A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA BY9CM4000

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention