BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION BASE PLATE INSERTER

    MDR report key: 1051900 · Received May 22, 2008

    Report

    Report Number
    1822565-2008-00266
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 18, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE GOUGES ON THE ENDS OF THE POSTS SUGGEST THAT IT HAS BEEN IMPACTED AGAINST THE SCREW CAPS USED WITHIN THE BASE PLATE, WHICH IS NOT PER TECHNIQUE. THE DESIGN INTENT OF THE FIT OF THE INSERTER TO THE BASE PLATE IS THAT THERE IS ALWAYS CLEARANCE BETWEEN THE ID OF THE BASE PLATE AND THE OD OF THE INSERTER. MATERIAL MAY HAVE BEEN TRAPPED BETWEEN THE TWO DEVICES, CAUSING INTERFERENCE AND PREVENTING THE INSERTER FROM RELEASING SATISFACTORILY. THE EXACT CAUSE CANNOT BE DEFINITIVELY DETERMINED. H6: AS RETURNED, THE TIPS OF THE TWO POSTS EXHIBIT GOUGING DEFORMATION DAMAGE. THE DEVICE MEETS SPECIFICATIONS AS MEASURED AND HAS A POTENTIAL FIELD AGE OF APPROX 1 1/2 YEARS. THE DEVICE HISTORY RECORDS ARE INTACT AND CONFIRMING, INDICATING THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT SURGERY WAS DELAYED FOR 20 MIN DUE TO THE FACT THAT THE BASE PLATE INSERTER WOULD NOT RELEASE THE BASE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION BASE PLATE INSERTER SHOULDER INSTRUMENT HSD ZIMMER, INC. NA 60605839

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK