BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER TRABECULAR METAL HUMERAL STEM

    MDR report key: 2063167 · Received March 22, 2011

    Report

    Report Number
    1822565-2011-00698
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: A MODIFIED SURGICAL TECHNIQUE AND NEW REAMERS WERE RELEASED IN (B)(6) 2010 BY ZIMMER FOR THE TM HUMERAL SHOULDER SYSTEM WHICH REQUIRES REAMING 1MM LARGER THAN THE INTENDED IMPLANT SIZE. THE NEW REAMERS AND SURGICAL TECHNIQUE WERE RELEASED AS PART OF THE CORRECTIVE ACTION ISSUED IN (B)(6) 2010. IT IS UNCLEAR IF THE SURGEON USED THE NEW REAMERS OR THE NEW TECHNIQUE. THE DEVICE WAS MEASURED AND FOUND CONFORMING. DAMAGE WAS OBSERVED ON THE TOP OF THE STEM THAT IS UNCHARACTERISTIC OF THE USE OF THE INSERTER. THE EXACT CAUSE OF FAILURE CANNOT BE DETERMINED WITH CERTAINTY. EVALUATION CODES: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. DIMENSIONAL ANALYSIS WAS PERFORMED. NO MANUFACTURING ABNORMALITIES COULD BE DETECTED BY EITHER METHOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON REAMED THE CANAL AND ATTEMPTED TO INSERT THE HUMERAL STEM BUT THE IMPLANT WAS TOO SMALL. THE SURGEON REAMED AGAIN AND THE NEXT SIZE IMPLANT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TRABECULAR METAL HUMERAL STEM KWT ZIMMER, INC. 61392760

    Patients

    Seq Age Sex Outcome Treatment
    1