BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TM/FM PROVISIONAL LOCKING SCREW

    MDR report key: 2182272 · Received July 12, 2011

    Report

    Report Number
    1822565-2011-01626
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 14, 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

    INFO WAS REC'D FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: IT IS UNK WHETHER THE PROPER SURGICAL TECHNIQUE WAS FOLLOWED. THE PROVISIONAL LOCKING SCREW IS DESIGNED SO THAT IT CAN BE DISASSEMBLED FROM THE PROVISIONAL LINER FOR CLEANING AND REPROCESSING. CARE SHOULD BE TAKEN WHEN REMOVING THE LINER SINCE THE SCREW AND PROVISIONAL CAN BE DISASSEMBLED. SHOULD THE SET SCREW FALL INTO THE WOUND, THE COMPONENT CAN BE EASILY DETECTABLE VIA X-RAY FOR EXTRACTION. IT IS UNK EXACTLY WHY THE SET SCREW FELL IN THE WOUND BUT A LIKELY CONTRIBUTING FACTOR IS THAT THE SET SCREW IS NOT ATTACHED TO THE LINER. 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 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 ADD'L SUBSTANTIVE INFO BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT AFTER TRIALING, THE SURGEON ATTEMPTED TO REMOVE THE TRIAL LINER. WHEN DOING SO, THE SET SCREW FELL INTO THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TM/FM PROVISIONAL LOCKING SCREW LXH ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR