BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN MIS TRABECULAR METAL TIBIAL TRAY

    MDR report key: 1844789 · Received September 23, 2010

    Report

    Report Number
    1822565-2010-00810
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Report Date
    August 30, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: X-RAY IMAGES WERE RETURNED FOR ANALYSIS. THE IMAGE OF THE X-RAY TAKEN 2.5 YEARS AFTER THE FALL APPEARS TO CONFIRM THE SURGEON'S REPORT THAT THERE IS A FRACTURE OF THE LATERAL PEG OF THE TIBIAL BASEPLATE. THE FRACTURE OF THE PEG IS LIKELY DUE TO THE PT'S FALL AND SUBSEQUENT FRACTURE OF THE TIBIAL PLATEAU. THE PROGRESSING MEDIAL COLLAPSE ALSO LIKELY CONTRIBUTED TO THE FRACTURE OF THE PEG. THE CAUSE OF THE FRACTURE IS NOT LIMITED TO THESE EVENTS, HOWEVER, SO A DEFINITE CAUSE CANNOT BE DETERMINED. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE RE-OPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT'S X-RAYS SHOW EVIDENCE OF MEDIAL COLLAPSE OF THE TIBIAL BASEPLATE. THE SURGEON HAS ALSO REPORTED THE PRESENCE OF A FRACTURE OF THE WELL-FIXED LATERAL PEG OFF OF THE TIBIAL PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN MIS TRABECULAR METAL TIBIAL TRAY KNEE PROSTHESIS JWH ZIMMER, INC. 60872308

    Patients

    Seq Age Sex Outcome Treatment
    1