BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIS INSTRUMENTATION LATERAL ALIGNMENT FRAME

    MDR report key: 5748170 · Received June 24, 2016

    Report

    Report Number
    0001822565-2016-02176
    Event Type
    Malfunction
    Date Received
    June 24, 2016
    Date of Event
    May 26, 2016
    Report Date
    March 17, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED ALIGNMENT FRAME DETERMINED THAT THE THUMB SCREW WAS FRACTURED AND O-RING PART 87-8800-012-00 WAS MISSING. FOLLOW UP CONFIRMED THAT THE O-RING WAS INADVERTENTLY DISCARDED. DIMENSIONAL EVALUATION VERIFIED THAT DIAMETER OF THE THREADED SHAFT, MATERIAL HARDNESS OF THE SCREW AND A-FRAME CONFORMED TO PRINT SPECIFICATIONS. NO IMPACTION MARKS WERE NOTED ON THE THUMB SCREW. THE THREADS OF THE A-FRAME DOVETAIL THREADED FEATURE FAILED THREAD GAUGE DUE TO DAMAGED THREADS. THE DEVICE EXHIBITS WEAR AND TEAR THAT INDICATING SUCCESSFUL USE. REVIEW OF RECEIVING INSPECTION REPORT VERIFIED THAT THE DEVICE CONFORMED TO SPECIFICATIONS. THE REPORTED DEVICE IS USED FOR TREATMENT. REVIEW OF COMPLAINT HISTORY IDENTIFIED NO PREVIOUS COMPLAINTS FOR THE PART LOT COMBINATION. BASED ON THE MANUFACTURE DATE, THE POTENTIAL FIELD AGE OF THE A-FRAME IS APPROXIMATELY TWO YEARS. THE FREQUENCY OF USE OF THIS INSTRUMENT IS UNKNOWN. BASED ON REVIEW OF THE RETURNED DEVICE A SPECIFIC CAUSE FOR THE BROKEN THUMB SCREW, DAMAGED DOVETAIL THREADED FEATURE COULD NOT BE DETERMINED WITH CERTAINTY.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT IS REPORTED THE CONNECTING SCREW OF THE A-FRAME WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401910 MIS INSTRUMENTATION LATERAL ALIGNMENT FRAME HIP INSTRUMENT LXH ZIMMER, INC. 62719487

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR