BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET BC R 1X40 US

    MDR report key: 24494034 · Received March 3, 2026

    Report

    Report Number
    3006946279-2026-00011
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    August 30, 2022
    Report Date
    March 3, 2026
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    UDI-DI
    00887868214578
    PMA / PMN Number
    K172408
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM NAME# VNGD ANT STBLZD BRG 10X83; ITEM NUMBER# 189120; LOT NUMBER# 764490; ITEM NAME# VANGUARD CR ILOK FEM-RT 75; ITEM NUMBER# 183014; LOT NUMBER# J7030081; ITEM NAME# BIOMET CC CRUCIATE TRAY 83MM; ITEM NUMBER# 141236; LOT NUMBER# J7053597; ITEM NAME# SERIES A PAT THIN 37X8.6 3 PEG; ITEM NUMBER# 184788; LOT NUMBER# 189710; ITEM NAME# BIOMET BC R 1X40 US; ITEM NUMBER# 110035368; LOT NUMBER# AZ43AJ2201. 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 PATIENT UNDERWENT A RIGHT TOTAL KNEE REVISION APPROXIMATELY 3 MONTHS POST-IMPLANTATION DUE TO PAIN, SWELLING, AND STIFFNESS. DURING THE REVISION, ABUNDANT SCAR TISSUE WAS REMOVED. THE PATELLAR BUTTON WAS FOUND DISPLACED WITH SHEARING THROUGH ALL THREE PEGS; THE PATELLA WAS REVISED, AND THE BEARING WAS REPLACED AND DOWNSIZED TO REDUCE JOINT TENSION. THE PATIENT WAS REVISED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558576 BIOMET BC R 1X40 US BONE CEMENT LOD BIOMET FRANCE S.A.R.L. AZ43AJ2201 00887868214578

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11 NARRATIVE