BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ZIMMER LPS-FEX FEMORAL TRIALS

    MDR report key: 1025590 · Received April 2, 2008

    Report

    Report Number
    1822565-2008-00149
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    November 1, 2006
    Report Date
    March 13, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: CAUSE CANNOT BE DEFINITIVELY DETERMINED. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO 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 INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING SURGERY AFTER THE BONE CUTS ARE MADE, THE TRIALS ARE TIGHTER IN FLEXION COMPARED TO EXTENSION. THIS REQUIRES THE SURGEON TO DO SOME ADDITIONAL RELEASES IN SOME CASES TO BALANCE THE GAPS. EXACT OCCURRENCE DATE IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER LPS-FEX FEMORAL TRIALS KNEE INSTRUMENT LXH ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK