BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION HUMERAL STEM IMPACTOR

    MDR report key: 1062775 · Received June 17, 2008

    Report

    Report Number
    1822565-2008-00327
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 13, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE INSTRUMENT SHOULD BE LUBRICATED WITH A WATER SOLUBLE LUBRICANT SUCH AS "INSTRUMENT MILK" PRIOR TO EACH SURGICAL PROCEDURE FOR PROPER FUNCTIONING OF THE DEVICE. CAUSE CANNOT BE DEFINITIVELY DETERMINED. THE RETURNED STEM IMPACTOR WAS FOUND CONFORMING TO FUNCTIONAL GAUGE. SOME STRIKE MARKS ARE OBSERVED ON THE BODY OF THE DEVICE. ADDITIONALLY, THE LOCKING PIN EXHIBITS SOME MINOR DEFORMATION DAMAGE FROM USE. THE DEVICE HAS A POTENTIAL FIELD AGE OF 1 1/2 YEARS. DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION. THE REPORTED MALFUNCTION HAS CAUSED OR CONTRIBUTED TO A SERIOUS INJURY IN THE PREVIOUS TWO YEARS ON A SAME OR SIMILAR DEVICE. AS A RESULT, THIS REPORT IS BEING SUBMITTED IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE DOCUMENT PUBLISHED BY THE FDA IN MARCH OF 1997.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE IMPACTOR WOULD NOT DISENGAGE FROM THE FINAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION HUMERAL STEM IMPACTOR SHOULDER INSTRUMENT HWA ZIMMER, INC. NA 60553395

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK