BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER MIS HIP HYBRID OFFSET SHELL INSERTER

    MDR report key: 2152381 · Received June 28, 2011

    Report

    Report Number
    1822565-2011-01527
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Report Date
    June 2, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE INSERTER WAS RETURNED HOWEVER THE HEX BOLT WAS NOT. IT IS LIKELY THAT THE HEX BOLT IS THE PORTION OF THE INSTRUMENT THAT ALLEGEDLY BROKE SINCE THE RETURNED INSERTER IS INTACT. THE INSERTER CONTAINS A DAMAGED RETAINING PIN INDICATING THAT THE HEX BOLT MAY HAVE BEEN REMOVED SEVERAL TIMES. THE DAMAGE NOTED ON THE STRIKE SURFACE IS CONSISTENT WITH USAGE OVER THE PAST 6 YEARS. IN ADDITION, THE INSTRUMENT CONTAINS DAMAGE ON THE KNURLED REGION AS WELL AS ALONG THE SHAFT OF THE INSTRUMENT INDICATIVE OF APPLYING NON-AXIAL LOADS. THE SURGICAL TECHNIQUE STATES "NOTE: DO NOT LEVER ON THE SHELL OR THE CUP INSERTER TO REPOSITION THE IMPLANT, AS DAMAGE MAY OCCUR TO THE THREADS OR INNER DIAMETER OF THE SHELL." IT IS POSSIBLE THAT THE INSTRUMENT WAS IMPACTED ON ITS SIDE ON THE KNURLED PORTION TO REPOSITION THE SHELL, WHICH MAY HAVE CONTRIBUTED TO THE ALLEGED BROKEN FAILURE. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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 ADD'L 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 THE HYBRID OFFSET SHELL INSERTER BROKE DURING A USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER MIS HIP HYBRID OFFSET SHELL INSERTER LXH ZIMMER, INC. 60346035

    Patients

    Seq Age Sex Outcome Treatment
    1