BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISIONAL LINER LOCKING SCREW

    MDR report key: 2193034 · Received July 22, 2011

    Report

    Report Number
    1822565-2011-01698
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    April 7, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETED FORM 3500A. EVAL SUMMARY: IT IS POSSIBLE THAT THE LOCKING SCREW/LINER WAS NOT PROPERLY ALIGNED FOR INSERTION MAKING ENGAGEMENT WITH THE MATING THREADS DIFFICULT. IF THE SCREW IS NOT PROPERLY ALIGNED, ADD'L STRESSES COULD BE PLACED ON THE LEADING THREAD POTENTIALLY LEADING TO CHIPPING. THE AGE OF THE LOCKING SCREW AND NUMBER OF USES IS UNK. IT IS UNK IF INSTRUCTIONS PER THE SURGICAL TECHNIQUE WERE FOLLOWED. WITH THE INFO PROVIDED, THE EXACT CAUSE CANNOT BE DETERMINED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFO, 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 WAS REPORTED THAT AFTER MULTIPLE ATTEMPTS TO ASSEMBLE THE PROVISIONAL LOCKING SCREW TO THE PROVISIONAL LINER, IT WAS NOTED THE LOCKING SCREW'S THREADS WERE CHIPPED OFF. THE WOUND WAS REPORTEDLY IRRIGATED IN THE NORMAL FASHION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVISIONAL LINER LOCKING SCREW LXH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR