BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATELLA TRIAL 35 MM

    MDR report key: 4001655 · Received April 23, 2014

    Report

    Report Number
    3004153240-2014-00047
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 2, 2014
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    PMA / PMN Number
    CLASS 1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    PERIODIC REVIEW OF ITEMS REMOVED FROM REUSABLE INSTRUMENT TRAYS DURING RE-PROCESSING WAS COMPLETED. REVIEW SHOWED THAT A PEG WAS BROKEN OFF OF ONE 35 MM PATELLA IMPLANT TRIAL. THERE IS NO INDICATION THAT A SURGERY WAS ADVERSELY IMPACTED. REVIEW OF INSPECTION RECORDS FOR THE AFFECTED LOT OF MATERIAL INDICATE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    PERIODIC REVIEW OF ITEMS REMOVED FROM REUSABLE INSTRUMENT TRAYS DURING RE-PROCESSING WAS COMPLETED. REVIEW SHOWED THAT A PEG WAS BROKEN OFF ONE 35 MM PATELLA IMPLANT TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246764 PATELLA TRIAL 35 MM REUSABLE PATELLAR IMPLANT TRIAL JWH CONFORMIS, INC. G1120

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown