BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN MIS STEMMED TIBIAL COMPONENT

    MDR report key: 5997941 · Received October 4, 2016

    Report

    Report Number
    0001822565-2016-03517
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    December 19, 2014
    Report Date
    November 29, 2016
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK043101
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: NEXGEN LPS-FLEX GSF FEMORAL COMPONENT OPTION, CATALOGUE # 00576401552, LOT # 60779312; NEXGEN MIS DROP DOWN STEM PLUG, CATALOGUE # 00595006700, LOT # 60411831; NEXGEN LPS-FLEX ARTICULAR SURFACE, CATALOGUE # 00596203214, LOT # 60512473; NEXGEN ALL POLY PATELLA, CATALOGUE # 00597206529, LOT # 60759304; PALACOS BONE CEMENT, CATALOGUE # 00111314001, LOT # 65584099. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORDS FOR THE FEMORAL COMPONENT (00-5764-015-52, LOT # 60779312), FOR THE TIBIAL COMPONENT (00-5950-037-02, LOT # 60616289), AND FOR THE STEM EXTENSION (00-5950-067-00, LOT # 60411831) WERE REVIEWED AND NO DEVIATIONS OR ANOMALIES WERE IDENTIFIED. THE QUALITY RECORDS OF THE BONE CEMENT WERE REVIEWED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. REVIEW OF THE COMPATIBILITY MATRIX CONFIRMED THAT THE DEVICES USED ARE COMPATIBLE. THESE DEVICES ARE USED FOR TREATMENT. A COMPLAINT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINT FOR THE PART/LOT COMBINATION OF THE FEMORAL OR TIBIAL COMPONENT. THE PRIMARY SURGICAL NOTES STATE THAT THE PATIENT UNDERWENT RIGHT TKA DUE TO SEVERE ARTHRITIS IN THE RIGHT KNEE. THE BONE CUTS WERE COMPLETED, THE MENISCI AND PCL WERE COMPLETELY EXCISED. THE TIBIAL CUT WAS MADE PERPENDICULAR TO THE 2ND RAY OF THE FOOT AND CHECKED WITH MULTIPLE ALIGNMENT RODS TO INSURE ACCURACY. A TRIAL REDUCTION WAS PERFORMED AND EXCELLENT STABILITY THROUGH ALL RANGES WAS INITIALLY ACHIEVED WITH A 14MM POLY. THE FINAL COMPONENTS WERE CEMENTED IN PLACE IN A NORMAL FASHION. EXCESS CEMENT WAS REMOVED. PULSATILE LAVAGE WITH THOROUGH IRRIGATION WAS USED ONCE AGAIN BEFORE WOUND CLOSURE. THE RANGE OF MOTION AND STABILITY WERE BOTH EXCELLENT. THE REVISION SURGICAL NOTES INDICATE THAT RADIOGRAPHS SHOWED OBVIOUS LOOSENING OF THE TIBIAL COMPONENT AND ABOUT 30 DEGREES OF VARUS. THERE WAS NO EVIDENCE OF INFECTION ON FROZEN SECTION AND NO FRANK PURULENCE. INTRA-OPERATIVELY, THE TIBIAL COMPONENT WAS FOUND TO BE OBVIOUSLY LOOSE AND REMOVED WITH A POWER OSTEOTOME AND BONE TAMP. THERE APPEARED TO BE CYSTIC DEGENERATION OF THE MEDIAL ASPECT OF THE TIBIAL PLATEAU IN THE VICINITY OF SUBSIDENCE, WHICH RESULTED IN VARUS DEFORMITY. THE FEMORAL COMPONENT WAS ALSO LOOSENED IN A SIMILAR FASHION. PER THE PACKAGE INSERTS OF THE COMPONENTS, PAIN AND LOOSENING OF THE PROSTHETIC KNEE COMPONENTS ARE KNOWN POTENTIAL ADVERSE EFFECTS OF THE TKA PROCEDURE. THE INSERT ALSO WARNS THAT COMPLICATIONS AND/OR FAILURE OF TOTAL KNEE PROSTHESES ARE MORE LIKELY TO OCCUR IN HEAVY PATIENTS. 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 HAS BEEN REPORTED THAT FOLLOWING A KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO PAIN AND TIBIAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649285 NEXGEN MIS STEMMED TIBIAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC. 60616289

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R