BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN MOBILE FLUTED STEMMED TIBIAL PLATE

    MDR report key: 4502156 · Received February 3, 2015

    Report

    Report Number
    1822565-2015-00118
    Event Type
    Injury
    Date Received
    February 3, 2015
    Date of Event
    October 29, 2012
    Report Date
    January 6, 2015
    Manufacturer
    ZIMMER, INC.
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THIS PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PROD FAILED TO MEET SPEC. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PROD CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS FOR TIBIAL COMPONENT DID NOT FIND ANY DEVIATIONS OR ANOMALIES. MEDICAL RECORDS FOR THE PRIMARY SURGERY WAS RECEIVED. IT WAS CONFIRMED THAT PATIENT UNDERWENT BILATERAL TOTAL KNEE ARTHROPLASTIES DUE TO DEGENERATIVE JOINT DISEASE IN BOTH THE KNEES. PER THE SURGICAL NOTES FOR THE LEFT SIDE; DURING THE SURGERY, EXCELLENT RANGE OF MOTION GOING FROM FULL EXTENSION TO GREATER THAN 120 DEGREES OF FLEXION WAS ACHIEVED. EXCELLENT VARUS AND VALGUS STABILITY IN BOTH FULL EXTENSION AS WELL AS MIDFLEXION WAS ALSO ACHIEVED. THE PATIENT WAS IN GOOD CONDITION WITHOUT COMPLICATIONS POST-OPERATIVELY. PER THE REPORT, THE PATIENT WAS REVISED DUE TO LOOSENING; REVISION OPERATIVE NOTES WERE NOT PROVIDED AND HENCE LOOSENING OF THE IMPLANTS CANNOT BE CONFIRMED. IT WAS REPORTED THAT SIMPLEX BONE CEMENT WAS USED IN THE PRIMARY SURGERY, WHICH IS NOT A ZIMMER BIOMET PRODUCT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77676 NEXGEN MOBILE FLUTED STEMMED TIBIAL PLATE NJL NJL ZIMMER, INC. 60969391

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention