BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 3192010 · Received June 20, 2013

    Report

    Report Number
    1822565-2013-01000
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: PHOTOGRAPHS OF THE CEMENT MANTLE AND OF THE REMOVED TIBIAL COMPONENT WERE RETURNED. THE TIBIAL COMPONENT SHOWS NO SIGNS OF CEMENT ADHERING TO THE UNDERSIDE OF THE BASEPLATE. THE (B)(4) ON THE BONE SHOWS OUTLINES OF THE TIBIAL COMPONENT WHERE THEY WERE PRESSED TOGETHER AND IS ALMOST COMPLETELY INTACT WITH NO INDICATIONS OF ADHERENCE TO THE TIBIAL PLATE. THE ANTERIOR MEDIAL PORTION OF THE TIBIAL CEMENT MANTLE IS FRACTURED OFF, LIKELY CAUSED DURING EXTRACTION. IT IS POSSIBLE THAT THE CEMENT WAS ALLOWED TO CURE TOO LONG PRIOR TO PUSHING THE TIBIAL COMPONENT IN PLACE. HOWEVER, SURGICAL NOTES WERE NOT PROVIDED, THEREFORE, IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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 AVAILABLE INFORMATION, 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 PT WAS REVISED DUE TO PAIN AND LOOSENING OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281247 NEXGEN STEMMED TIBIAL COMPONENT JWH ZIMMER, INC. 61744967

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention