BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUUM TRILOGY ALLOFIT DOME IMPACTOR

    MDR report key: 1872331 · Received October 12, 2010

    Report

    Report Number
    1822565-2010-00875
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 2010
    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: REVIEW OF THE RETURNED PRODUCT INDICATES DAMAGE TO THE CONNECTION END AND ALSO THE DOME. IT IS ALSO NOT KNOWN WHETHER A UNIVERSAL HANDLE WAS USED WITH THIS INSTRUMENT OR NOT. DOME ADAPTER FRACTURE MAY BE CAUSED DUE TO ONE OR A COMBINATION OF THE FOLLOWING FACTORS: DAMAGE CAUSED DUE TO REPEATED CLEANING OR AUTOCLAVING. DAMAGE CAUSED DUE TO IMPROPER ATTACHMENT USED WITH THIS DEVICE. HEAVY IMPACTION FORCE. THIS IS NOT AN EXHAUSTIVE LIST. HOWEVER, NO DEFINITE CAUSE ANALYSIS CAN BE DETERMINED WITH CERTAINTY. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT UPON IMPACTION, THE GREEN 36 DOME IMPACTION ADAPTER BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUUM TRILOGY ALLOFIT DOME IMPACTOR HIP INSTRUMENT HWA ZIMMER INC. 61420981

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR