BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD SSK PSC INTLK FMRL 60 LT

    MDR report key: 23450667 · Received November 3, 2025

    Report

    Report Number
    0001825034-2025-03425
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    October 8, 2025
    Report Date
    January 13, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K042757
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. UPDATED: B4, B5, D2B, G1, G3, G6, H1, H2, H3, H6, H10, AND H11. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT IS NOT 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10- MEDICAL PRODUCT VNGD SSKPSC TIB BRG S 12X63/67 ITEM# 183822 LOT# 762040. VG 360 DST FM AG 60X15 LL/RM ITEM# 185482 LOT# 65897159. VG 360 DST FM AG 60X5 RL/LM ITEM# 185302 LOT# 66116801. VG 360 UNIV PST FM AUG 60X5 ITEM# 185342 LOT# 970970. BMT SPLINED KNEE STM V2 16X120 ITEM# 148319 LOT# 550030. VNGD SSK PSC TIB BRG 18X63/67 ITEM# 183868 LOT# 65954079. BIOMET TIBIAL LOCKING BAR ITEM# 141205 LOT# 67144048. VAN SSK360 FMRL CSTG, 60MM LT ITEM# 185282-02 LOT# 7076794. H3- CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT 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.

    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 A PATIENT WAS REVISED DUE TO INSTABILITY AND FEMORAL LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1799169 VNGD SSK PSC INTLK FMRL 60 LT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 211520

    Patients

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