BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TM REVERSE GLENOSPHERE DISTRACTOR

    MDR report key: 3236279 · Received July 11, 2013

    Report

    Report Number
    1822565-2013-01093
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Removal / Correction Number
    1822565-7/09/2013/005-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. BASED ON COMMUNICATION WITH THE SALES REPRESENTATIVE, ONCE THE DEVICE WAS LUBRICATED, IT DOES FUNCTION AS DESIGNED. THE ZIMMER "INSTRUMENT CARE, CLEANING AND STERILIZATION INSTRUCTION" BOOKLET STATES THAT HINGES, THREADS, AND OTHER MOVING PARTS SHOULD BE LUBRICATED USING A COMMERCIAL, WATER-SOLUBLE, SURGICAL GRADE LUBRICANT PRIOR TO STERILIZATION. THE DESIGN OF THE DISTRACTOR WAS MODIFIED AND IN JULY 2013, A RECALL WAS INITIATED TO REMOVE THE DISTRACTORS PRODUCED PRIOR TO THE CHANGES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE INSTRUMENT WOULD NOT FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319970 TM REVERSE GLENOSPHERE DISTRACTOR HSD ZIMMER, INC. 61918666

    Patients

    Seq Age Sex Outcome Treatment
    1