BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER TRABECULAR METAL HUMERAL STEM

    MDR report key: 1782958 · Received July 28, 2010

    Report

    Report Number
    1822565-2010-00532
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    June 8, 2010
    Report Date
    June 18, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Removal / Correction Number
    1822565-07/26/2010-006-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE NOMINAL FIT OF THE IMPLANT TO THE BONE PREPARATION IS INTENDED TO PROVIDE AN INTERFERENCE FIT CONDITION TO PROVIDE MECHANICAL STABILITY IN THE ABSENCE OF BONE CEMENT. DEPENDING ON PT BONE QUALITY, AND THE AMOUNT OF BONE REMOVED, THE REMAINING BONE MAY NOT ALLOW THE IMPLANT TO SEAT WITH NORMAL IMPACT FORCES IN SOME CASES. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE OCCURRENCE SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IS IMPLEMENTING CORRECTIVE ACTION. REFERENCE REMOVAL REPORT 1822565-7/26/2010-006-R FOR ADDITIONAL INFO REGARDING THE CORRECTIVE ACTION TAKEN. 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 ADDITIONAL 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 UP TO 14MM IN ORDER TO GET THE STEM TO PRESS FIT IN THE CANAL. SURGERY WAS PROLONGED BY ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TRABECULAR METAL HUMERAL STEM SHOULDER PROSTHESIS HSD ZIMMER, INC. 61370963

    Patients

    Seq Age Sex Outcome Treatment
    1