BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 4092107 · Received August 21, 2014

    Report

    Report Number
    2648920-2014-00212
    Event Type
    Injury
    Date Received
    August 21, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ZIMMER TURPEAUX INDUSTRIAL PARK
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS BONE CEMENT IS MANUFACTURED AT HERAEUS MEDICAL AND DISTRIBUTED THROUGH (B)(4). EVALUATION SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WER NOT PROVIDED; 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 INFO PROVIDED. EVALUATION CODES: 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 INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER INC CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    NEW INFORMATION CONTAINING PRIMARY AND REVISION OP-NOTES WAS RECEIVED AND REVIEWED. THE PRIMARY SURGICAL NOTES INDICATE THAT THE OVERWEIGHT/OBESE PATIENT UNDERWENT TKA FOR SEVERE OSTEOARTHRITIS OF THE RIGHT KNEE. WITH TRIAL COMPONENTS IN PLACE THE KNEE HAD GOOD STABILITY AND THE PATELLA TRACKED NICELY THROUGH THE FULL RANGE OF MOTION. THE FINAL TIBIAL AND FEMORAL COMPONENTS WERE CEMENTED IN PLACE AND THE KNEE PUT IN FULL EXTENSION UNTIL CEMENT HARDENED. EXCESS CEMENT WAS REMOVED. THE REVISION SURGICAL NOTES INDICATE THAT THE TIBIAL COMPONENT WAS LOOSE. PER THE PACKAGE INSERT OF THE TIBIAL COMPONENT, LOOSENING OF THE PROSTHETIC KNEE COMPONENTS IS A KNOWN ADVERSE EFFECT OF THIS PROCEDURE. THE INSERT ALSO STATES THAT COMPLICATIONS AND/OR FAILURE OF TOTAL KNEE PROSTHESES ARE MORE LIKELY TO OCCUR IN HEAVY PATIENTS. THIS DEVICE IS USED FOR TREATMENT. A PREVIOUS INVESTIGATION OF THIS ISSUE CONCLUDED THAT THERE IS NO EVIDENCE THAT ANY DESIGN RELATED OR MANUFACTURING RELATED FACTORS ARE INFLUENCING LOOSENING OF THE IMPLANT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN, WEAR, OSTEOLYSIS, AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504654 NEXGEN STEMMED TIBIAL COMPONENT JWH ZIMMER TURPEAUX INDUSTRIAL PARK 61229783

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention LOT #68164202