BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KGS BIOMET CC CRUCIATE TRAY 71MM

    MDR report key: 23879713 · Received December 23, 2025

    Report

    Report Number
    0001825034-2025-04167
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    November 27, 2025
    Report Date
    March 13, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K915132
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H11. THE FOLLOWING SECTIONS WERE CORRECTED: D4, E2, G4. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW; HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2; H6 THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 183640, VNGD PS TIB BRG 10X71/75MM, (B)(6). 183122, VAN PS OPEN INTL FEM-LT 57.5, (B)(6). G2: FOREIGN - EVENT OCCURRED IN JAPAN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WHO PREVIOUSLY UNDERWENT A TOTAL KNEE ARTHROPLASTY WAS REVISED APPROXIMATELY 15 YEARS POST-IMPLANTATION DUE TO A BONE FRACTURE. DURING THE REVISION, ALL KNEE COMPONENTS WERE EXCHANGED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1918777 KGS BIOMET CC CRUCIATE TRAY 71MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 425570

    Patients

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