BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD CR TIB BRG 16X63/67

    MDR report key: 18134665 · Received November 14, 2023

    Report

    Report Number
    0001825034-2023-02555
    Event Type
    Injury
    Date Received
    November 14, 2023
    Date of Event
    October 13, 2023
    Report Date
    April 25, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304271081
    PMA / PMN Number
    K023546
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCT: VNGD CR TIB BRG 16X63/67: CATALOG#183426, LOT#166860; UNKNOWN VANGUARD TIBIAL TRAY: CATALOG#NI, LOT#NI. G2: FOREIGN: GERMANY. MULTIPLE MDR REPORTS HAVE BEEN FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0001825034-2023-02666. DILIGENCE IS IN PROCESS TO DETERMINE WHETHER THE PRODUCT IS AVAILABLE FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PRODUCT COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. THE PATIENT DID NOT CONSENT FOR EVALUATION OF THE EXPLANTED DEVICE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT PRESENTS WITH KNEE INSTABILITY, VALGUS LEG DEFORMITY VISIBLE ON EXAM; ¿WHEN THE INLAY IS REMOVED, IT IS FOUND THAT THE POSTERIOR WALL HAS BEEN SHEARED LATERALLY.¿ POLY FRAGMENTS REMOVED WITH SUCTION AND FORCEPS; SURGEON STATES PATIENT¿S MORBID OBESITY, PCL INSUFFICIENCY, AND POSSIBLE INCORRECT ROTATION OF THE TIBIAL COMPONENT COULD BE CONTRIBUTING FACTORS. RADIOGRAPHS WERE PROVIDED BUT NOT REVIEWED AS THE X-RAYS PROVIDED WERE TAKEN POST-REVISION, THEREFORE THE REVIEW WOULD NOT ENHANCE THE INVESTIGATION. ROOT CAUSE WAS UNABLE TO BE DETERMINED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PROVIDED MEDICAL RECORDS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. ON AN UNKNOWN TIMEFRAME POST-IMPLANTATION, THE PATIENT PRESENTED WITH INSTABILITY AND A VALGUS DEFORMITY IN THE KNEE. SUBSEQUENTLY, A REVISION SURGERY WAS PERFORMED. DURING THE SURGERY IT WAS NOTED THAT THE TIBIAL COMPONENT WAS SLIGHTLY ROTATED AND THE INLAY WAS SHEARED OFF AT THE POSTERIOR WALL HOWEVER THE TIBIAL AND FEMORAL COMPONENTS WERE FREE OF VISIBLE DEFORMITIES AND WERE LEFT INTACT. THE SURGEON REPLACED THE ARTICULAR SURFACE WITH A THICKER, ANTERIOR-STABILIZING INLAY TO SUPPORT AND INCREASE THE PATIENT'S LIGAMENT TENSION. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2041850 VNGD CR TIB BRG 16X63/67 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 166860 00880304271081
    2101778 VNGD CR TIB BRG 16X63/67 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 166860 00880304271081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H10 NARRATIVE.