BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN MIS STEMMED TIBIAL COMPONENT

    MDR report key: 2080979 · Received April 13, 2011

    Report

    Report Number
    2648920-2011-00015
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 17, 2011
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: ONLY THE DROP DOWN STEM EXTENSIONS WERE RETURNED FOR EVALUATION. ALL MEASUREMENTS TAKEN WERE CONFORMING; THE THREADS WERE VERIFIED USING THE APPLICABLE GAGE AND FOUND CONFORMING. VISUAL INSPECTION SHOWS NO SCRATCHES OR CHIPS; BOTH PARTS LOOK BRAND NEW. WITHOUT ADDITIONAL INFORMATION, THE EXACT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. DIMENSIONS TAKEN ARE WITHIN SPECIFICATION. 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 REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON WAS NOT ABLE TO INSERT THE DROP DOWN SEM INTO THE TIBIA PLATE, SO HE COMPLETED THE SURGERY WITHOUT THE DROP DOWN STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN MIS STEMMED TIBIAL COMPONENT JWH ZIMMER 61627193

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 00595006775, LOT #61604427| PROCEDURE DROP DOWN STEM EXTENSION: CATALOG #| BOTH MANUFACTURED AT ZIMMER INC., (B)(4)| PROCEDURE DROP DOWN STEM EXTENSION: CATALOG #| NEXGEN COMPLETE KNEE SOLUTION MIS TOTAL KNEE| NEXGEN COMPLETE KNEE SOLUTION MIS TOTAL KNEE| 00595006745, LOT #61609936