BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN COMPLETE KNEE TIBIAL BROACH IMPACTOR

    MDR report key: 1950104 · Received December 7, 2010

    Report

    Report Number
    1822565-2010-01284
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    1822565-03/18/2010-004R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THUMB PINS LOOSEN AS A RESULT OF THE DETERIORATION OF THE EPOXY BOND BETWEEN THE THUMB PIN AND THE INNER SHAFT. THIS DEVICE HAD A POTENTIAL FIELD AGE OF APPROX 6 YEARS AT THE TIME OF FAILURE. EVAL: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MFG AND INSPECTED TO SPEC. AS RETURNED, THE THUMB PIN ON THE DEVICE IS MISSING.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHILE THE SURGEON WAS BROACHING, THE LEVER OF THE IMPACTOR CAME OFF AND HAD TO BE REMOVED FROM THE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE TIBIAL BROACH IMPACTOR KNEE INSTRUMENT JWH ZIMMER, INC. 60194573

    Patients

    Seq Age Sex Outcome Treatment
    1