BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TC3 RP TIBIAL INSERT S3,25.0

    MDR report key: 1948298 · Received December 30, 2010

    Report

    Report Number
    1818910-2010-10287
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    P830055/S113
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT HAS BEEN REOPENED AND THE DECISION MADE TO REPORT THE ISSUE TO THE FDA PURSUANT TO A HEALTH HAZARD EVAL MEETING HELD (B)(4) 2010 IN WHICH A POTENTIAL RISK TO HEALTH WAS IDENTIFIED. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DEPUY WARSAW RETURNS INSPECTION REPORTS THE OUTER PEEL POUCH PACKAGING COMPONENT HAS AN INCOMPLETE SEAL. COMPLAINT IS BEING REOPENED PURSUANT TO A DETERMINATION MADE IN A HEALTH HAZARD EVAL MEETING HELD (B)(6) 2010 IN WHICH A POTENTIAL RISK TO HEALTH WAS IDENTIFIED, PER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TC3 RP TIBIAL INSERT S3,25.0 87NJL NJL DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA EH5BG4000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA