BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION GLENOSPHERE DISTRACTOR

    MDR report key: 1062742 · Received June 17, 2008

    Report

    Report Number
    1822565-2008-00325
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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. THE SURGICAL TECHNIQUE INSTRUCTS TO WEDGE THE FIN TIP BETWEEN THE SUPERIOR GLENOID BONE AND THE UNDERSIDE OF THE GLENOSPHERE. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: AS RETURNED, THE DISTRACTOR EXHIBITS INTERMITTENT OPERATION. INSTRUMENT LUBE WAS APPLIED TO THE DISTRACTOR AND THE OPERATION REMAINED INTERMITTENT. THE DEVICE EXHIBITS SIGNIFICANT RUST ON MULTIPLE COMPONENTS INDICATING LIKELY IMPROPER CLEANING AND MAINTENANCE. DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT SURGERY WAS DELAYED FOR 45 MINS DUE TO THE DISTRACTOR NOT WORKING CORRECTLY. WHEN THE GLENOSPHERE FINALLY CAME OUT OF THE ENTIRE UNIT, INCLUDING THE LOCKING SCREWS AND PARTS OF THE GLENOID BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION GLENOSPHERE DISTRACTOR SHOULDER INSTRUMENT HSD ZIMMER, INC. NA 60531990

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R