BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISIONAL LINER LOCKING SCREW

    MDR report key: 2192903 · Received July 23, 2011

    Report

    Report Number
    1822565-2011-01709
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 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

    EVAL SUMMARY: IT IS UNK IF INSTRUCTIONS PER THE SURGICAL TECHNIQUE WERE FOLLOWED. THE PROVISIONAL LOCKING SCREW WAS DESIGNED SO THAT IT CAN BE ASSEMBLED AND DISASSEMBLED FROM THE PROVISIONAL LINER FOR DEVICE REPROCESSING. THE ITEM AND LOT NUMBER OF PROVISIONAL LINER USED WITH THE REPORTED SCREW ARE UNK. IF THE SCREW IS NOT PROPERLY ALIGNED WITH THE MATING THREADS OF THE IMPLANT/PROVISIONAL SHELL, THE SCREW MAY NOT GO IN. THE CONDITION OF THE SCREW AND LINER ARE UNK. WITH THE INFO PROVIDED, THE EXACT CAUSE OF THE ISSUE CANNOT BE DETERMINED. 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 SPECIFICATIONS. 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 ADDITIONAL 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 THE SCREW WOULD NOT THREAD INTO THE ACETABULAR CUP ON MULTIPLE ATTEMPTS.

    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 76 YR