BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIB. BASEPLATE NK W/STEM NP 1

    MDR report key: 8486474 · Received April 5, 2019

    Report

    Report Number
    0001822565-2019-01387
    Event Type
    Injury
    Date Received
    April 5, 2019
    Date of Event
    February 8, 2019
    Report Date
    July 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K934695
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2019 - 02043.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER: (B)(4). REPORT SOURCE: (B)(6). CUSTOMER HAS NOT INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE DUE TO THE TIBIA BASEPLATE FRACTURE WITH HIGH OSTEOLYSIS AND DISTINCT METALLOSIS PLUS ANTHRACITE DISCOLORATION APPROXIMATELY THREE YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281319 TIB. BASEPLATE NK W/STEM NP 1 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 1418326

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R 620005809 1418268 SF-CON TIB INS| 6210-00-010 1393884 FEMUR NK-PRIM