BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-RT 62.5

    MDR report key: 23933798 · Received December 31, 2025

    Report

    Report Number
    0001825034-2025-04243
    Event Type
    Injury
    Date Received
    December 31, 2025
    Date of Event
    December 31, 2025
    Report Date
    April 17, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304270398
    PMA / PMN Number
    K171054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10- MEDICAL PRODUCT. VNGD CR TIB BRG 10X63/67, ITEM# 183420, LOT# 911740, BIOMET ILOK PRI TIB TRAY 67MM, ITEM# 141212, LOT# 982290, SERIES A PAT STD 31 3 PEG, ITEM# 184764, LOT# 833420, BIOMET FINNED PRI STEM 40MM, ITEM# 141314, LOT# 138020. H3- CUSTOMER HAS INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PROPOSED ANNEX G CODE: MECHANICAL (G04) ¿ FEMUR.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. UPDATED: B3, B4, B5, B7, D2B, D4, D6A, D9, G1, G3, G6, H1, H2, H3, H4, H6, AND H11. D6A. INITIAL SURGERY: (B)(6) 2018. VISUAL EXAMINATION OF THE RETURNED FEMORAL DEVICE IDENTIFIED SIGNS OF USE WITH GOUGES, BONE CEMENT AND BIO-DEBRIS PRESENT. THE DEVICE WAS ALSO WORN FROM CONTACT WITH THE TIBIAL COMPONENT. SEM ANALYSIS OF THE RETURNED COMPONENTS IDENTIFIED A CORRESPONDING MARK ON THE FEMORAL COMPONENT LIKELY DUE TO PROLONGED ARTICULATION OF THE FEMORAL COMPONENT AGAINST THE TIBIAL TRAY. THERE WAS ALSO A SIMILAR MARK ON THE OPPOSITE SIDE OF THE FEMORAL COMPONENT BUT WITH NO SIMILAR VISIBLE DAMAGE TO THE TIBIAL TRAY. DIMENSIONAL ANALYSIS OF THE PRODUCT DETERMINED THAT THE PRODUCT, WHERE MEASURED, WAS CONFORMING TO PRINT SPECIFICATIONS. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT IS CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY SEVEN YEARS SEVEN AND A HALF MONTHS POST IMPLANTATION DUE TO COLLAPSE OF THE IMPLANT ON ONE SIDE CAUSING PAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY SEVEN YEARS SEVEN AND A HALF MONTHS POST IMPLANTATION DUE TO COLLAPSE OF THE IMPLANT ON ONE SIDE CAUSING PAIN. THE PATIENT EXPERIENCED PAIN WHEN BEARING WEIGHT ON THE OPERATIVE KNEE, PAIN WHEN WALKING, INABILITY TO CLIMB OR DESCEND STAIRS DUE TO SIGNIFICANT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2792670 VANGUARD CR ILOK FEM-RT 62.5 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. J6178746 00880304270398

    Patients

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