BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER UNICOMPARTMENTAL ARTICULAR SURFACE PRO

    MDR report key: 1679481 · Received May 6, 2010

    Report

    Report Number
    1822565-2010-00271
    Event Type
    Malfunction
    Date Received
    May 6, 2010
    Date of Event
    April 8, 2010
    Report Date
    April 8, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: PART IS INDENTED AND DIMENSIONALLY MEETS SPECS. AS RETURNED, THE ARTICULAR SURFACE PROVISIONAL IS FRACTURED ALONG ONE OF THE CHANNELS. THIS FAILURE HAS BEEN REMEDIED VIA FORMAL CORRECTIVE AND PREVENTIVE ACTIONS. AN INCREASE IN CORNER RADIUS REDUCES THE STRESS CONCENTRATION, THUS REDUCING THE LIKELIHOOD OF A FRACTURE. THE PART HAS A POTENTIAL FIELD AGE OF OVER 4 YEARS AND THE NEW DESIGN WAS IMPLANTED IN (B)(6) 2008, THEREFORE, THESE PARTS WERE MADE PRIOR TO THIS DESIGN CHANGE. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES, MEANING THE DEVICE WAS MANUFACTURED, INSPECTED AND PACKAGED TO SPECIFICATION. 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 ADD'L SUBSTANTIVE INFO BE REC'D, A COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    THE TIBIAL TRIAL BROKE IN SITU WHILE TESTING RANGE OF MOTION BEFORE SELECTING FINAL IMPLANTS. ALL PIECES WERE REMOVED AND NO HARM WAS DONE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER UNICOMPARTMENTAL ARTICULAR SURFACE PRO KNEE INSTRUMENT LXH ZIMMER, INC. NA 60355109

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR