BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS TIB BRG 10X79/83MM

    MDR report key: 23511248 · Received November 10, 2025

    Report

    Report Number
    0001825034-2025-03537
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    October 14, 2025
    Report Date
    December 15, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K023546
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCT: SERIES A PAT W/WR THN 28 1 PEG: CATALOG#184722, LOT#855040; BIOMET ILOK PRI TIB TRAY 79MM: CATALOG#141215, LOT#958730; BIOMET FINNED PRI STM 80X12.5: CATALOG#141318, LOT#137450; VNGD PS OPEN POR FMRL LT 72.5: CATALOG#184533, LOT#178880. G2: FOREIGN: AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNING FOR FURTHER EVALUATION PER HOSPITAL POLICY. THE INVESTIGATION IS IN PROGRESS. UPON 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4; B5; G3; H2; H3; H6; H10; H11. VISUAL EXAMINATION OF THE PROVIDED PHOTOGRAPHS IDENTIFIED A FRACTURED POST ON A WORN ARTICULAR SURFACE AND A WORN PATELLA COMPONENT. THE DEVICES SHOW SIGNS OF WEAR SUCH AS ABRASIONS, MATERIAL LOSS, AND DISCOLORATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PROVIDED PHOTOGRAPHS. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. X-RAYS WERE PROVIDED AND REVIEWED A THIRD PARTY HEALTHCARE PROFESSIONAL. FINDINGS INDICATE THAT CROSS TABLE LATERAL IMAGING OF THE LEFT KNEE SHOWS A TOTAL KNEE ARTHROPLASTY WITH CEMENTED TIBIAL AND PATELLAR COMPONENTS IN PLACE, WITH NO RADIOLUCENCY AROUND THE COMPONENTS AND NO COMPONENT MALALIGNMENT. NO BONE CHANGES OR FRACTURES ARE OBSERVED. THE SUPERIOR RECESS IS NOT INCLUDED IN THE FIELD OF VIEW, SO EVALUATION FOR KNEE EFFUSION OR DISPLACED POLYETHYLENE FRAGMENTS IS LIMITED. THE IMAGING DOES NOT VISUALIZE A COMPLICATION ON THIS SINGLE LATERAL VIEW. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 TOTAL KNEE ARTHROPLASTY. APPROXIMATELY FOURTEEN (14) YEARS AND FIVE (5) MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO A FRACTURED POST OF THE ARTICULAR SURFACE. THE PATELLA IMPLANT ALSO EXHIBITED WEAR AND WAS EXCHANGED. IT WAS REPORTED THAT ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1962551 VANGUARD PS TIB BRG 10X79/83MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 140520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11 NARRATIVE.