BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUUM TRILOGY PROVISIONAL LOCKING SCREW

    MDR report key: 2182265 · Received July 12, 2011

    Report

    Report Number
    1822565-2011-01615
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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 IF INSTRUCTIONS PER 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. THE SCREW MAY HAVE DISLODGED DURING LINER INSERTION IF THE SCREW WAS NOT PROPERLY ALIGNED WITH THE MATING THREADED HOLE IN THE IMPLANT/PROVISIONAL SHELL AND PRESSURE WAS APPLIED TO THE LINER. HOWEVER, A DEFINITIVE ROOT CAUSE ANALYSIS CANNOT BE CONDUCTED WITH CERTAINTY AT THIS TIME BASED ON THE PROVIDED INFO. 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 IT TOOK SEVERAL ATTEMPTS TO ENGAGE THE TRIAL LINER. THE SCREW FELL INTO WOUND AND WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUUM TRILOGY PROVISIONAL LOCKING SCREW LXH ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR