BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITOTAL G2

    MDR report key: 2900122 · Received December 27, 2012

    Report

    Report Number
    3004153240-2012-00111
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 11, 2012
    Manufacturer
    CONFORMIS
    Product Code
    JWH
    PMA / PMN Number
    K120316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PEG ON THE BACK OF THE FEMORAL TRIAL DISPOSABLE INSTRUMENT BROKE OFF DURING INSPECTION. THE TAB THAT SECURES THE DISPOSABLE FEMORAL IMPACTOR TIP TO THE IMPACTOR HANDLE BROKE OFF DURING IMPACTION. THERE WAS NO ADVERSE IMPACT. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPEC.

    Description of Event or Problem · 1

    THE PEG ON THE BACK OF THE FEMORAL TRIAL DISPOSABLE INSTRUMENT BROKE OFF DURING IMPACTION. THE TAB THAT SECURES THE DISPOSABLE FEMORAL IMPACTOR TIP TO THE IMPACTOR HANDLE BROKE OFF DURING IMPACTION. THERE WAS NO ADVERSE PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITOTAL G2 TOTAL KNEE REPLACEMENT SYSTEM JWH CONFORMIS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR