BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXATION SCREW

    MDR report key: 8851823 · Received August 1, 2019

    Report

    Report Number
    0001822565-2019-03244
    Event Type
    Injury
    Date Received
    August 1, 2019
    Date of Event
    February 8, 2019
    Report Date
    August 1, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K931651
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 630000410 1418326, TIB. BASEPLATE NK W/STEM NP 1; 621000010 1393884, FEMUR NK-PRIM, COCR, PC, 1 L; 6200-05-809 1418268, SF-CON TIB INS LT SZ1/2 9. REPORT SOURCE: FOREIGN COUNTRY: (B)(6). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EVALUATION OF RETUNED TIBIAL PLATE AND ARTICULAR SURFACE NOTED TO BE FRACTURED. HOWEVER, FEMUR DOESN¿T SHOW ANY DAMAGES. THE FRACTURED TIBIAL PLATE WAS SUBMITTED FOR FURTHER ANALYSIS. SEM ANALYSIS DETERMINED FRACTURE IN THE TIBIAL PLATE SURFACE ARTIFACTS SUGGEST POSSIBLE FATIGUE FRACTURES ORIGINATING NEAR THE ANTERIOR-MEDIAL RIDGE. THE INFERIOR-LATERAL BASEPLATE SURFACES SHOW WHAT APPEARS TO BE BONE CEMENT INTERDIGITATION BUT VERY LITTLE ON THE MEDIAL SIDE. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED ADVANCED METALLOSIS DISCOLORED SYNOVIUM. IT WAS ALSO NOTED ROM EXTENSION/FLEXION 0-15 TO 80 DEGREE, THE TIBIAL COMPONENT WAS BROKEN AND EXTENSIVE OSTEOLYSIS IN THE AREA OF THE TIBIAL HEAD ARE FOUND BEFORE THE REVISION SURGERY. DURING THE REVISION, THE FEMORAL COMPONENT FOUND TO BE LOOSE AND PATELLA TENDON PARTIALLY IS TORN AWAY FROM THE TUBEROSITY, BUT IT WAS REPAIRED. PER PACKAGE INSERT NATURAL-KNEE II SYSTEM: PAIN, IMPLANT FRACTURE, AND LOOSENING ARE KNOWN ADVERSE EFFECTS OF THIS PROCEDURE. HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2019-01387, 0001822565-2019-02043.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 9 YEARS POST IMPLANTATION DUE TO PAIN AFTER EXPERIENCING A FALL. THE PATIENT STATED SHE HAD BEEN EXPERIENCING LEFT KNEE PAIN FOR APPROXIMATELY THREE YEARS PRIOR. THE X-RAY AND CT SCAN REVEALED MEDIAL FRACTURE OF THE TIBIAL BASE PLATE WITH DISLOCATION AND LARGE OSTEOLYSIS THROUGHOUT THE TIBIAL HEAD. DURING THE REVISION SURGERY, PRONOUNCED METALLOSIS WITH ANTHRACITE STAINED SYNOVIUM, COARSE LOOSENING OF THE TIBIAL BASE PLATE, AND LOOSENING OF THE FEMORAL COMPONENT WERE OBSERVED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644073 TIBIAL INSERT FIXATION SCREW PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 1418268

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R