BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGC DA2000 KN TIB BRG 71/75X8

    MDR report key: 24826190 · Received April 9, 2026

    Report

    Report Number
    3002806535-2026-00141
    Event Type
    Injury
    Date Received
    April 9, 2026
    Report Date
    April 9, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00889024229655. D10: 154808, AGC DA 2000 FEMORAL RIGHT 70MM, LOT: UNKNOWN. 154814, AGC DA 2000 TIBIAL TRAY 75MM, LOT: UNKNOWN. G2 ¿ FOREIGN ¿ AUSTRIA. G-4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS FDA PREMARKET SUBMISSION NUMBER [?] SUPPLEMENT NUMBER [?] K122745. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE REVISION OF THE BEARING IN THE PATIENT'S RIGHT KNEE IS PLANNED FOR THE BEGINNING OR MIDDLE OF ON (B)(6) 2026 DUE TO COMPONENT WEAR. THE SURGEON REQUESTED CUSTOM MADE BEARING, SIZE EIGHT MM FOR THE PATIENT, AS THERE IS NO COMMERCIALLY AVAILABLE OPTION THAT CAN REPLACE THE WORN COMPONENT. ACCORDING TO THE SURGEON, REMOVING THE WELL-FIXED TIBIAL AND FEMORAL IMPLANTS WOULD RESULT IN A LONGER SURGICAL AND RECOVERY TIME AND MORE BONE LOSS THAN A BEARING REPLACEMENT SURGERY. AN ESTIMATED REVISION SURGERY TIMING WAS CONFIRMED FOR OF BEGINNING OR MIDDLE OF ON (B)(6) 2026. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887986 AGC DA2000 KN TIB BRG 71/75X8 KNEE PROSTHESIS NRA BIOMET UK LTD. 1387817

    Patients

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