BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER TRABECULAR METAL HUMERAL STEM

    MDR report key: 2093430 · Received April 12, 2011

    Report

    Report Number
    1822565-2011-00906
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL 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. DEPENDING ON BONE QUALITY AND ANATOMY, THE AMOUNT OF PRESS FIT MAY BE LESS THAN DESIRED IN SOME SITUATIONS. THIS IS A SCENARIO THAT WAS ANTICIPATED DURING THE PREPARATION FOR AND IMPLEMENTATION OF THE AFOREMENTIONED CORRECTIVE ACTION. THE RISKS ASSOCIATED WITH HUMERAL STEMS FITTING LOOSE ARE SIGNIFICANTLY LOWER THAN WHEN STEMS FIT TIGHT. WITH THE INFO PROVIDED THE EXACT CAUSE CANNOT BE DETERMINED WITH CERTAINTY. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON REAMED PER SURGICAL TECHNIQUE FOR CORRESPONDING TRIAL AND STEM SIZE. THE DEPTH OF THE REAMER WAS CAREFULLY MONITORED. WHEN THE STEM WAS INSERTED IT WAS VERY LOOSE. AS A RESULT, THE SURGEON PROCEEDED TO CEMENT THE STEM IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TRABECULAR METAL HUMERAL STEM KWT ZIMMER, INC. 61124221

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR