BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD SSK PSC TIB BRG 16X63/67

    MDR report key: 21631680 · Received March 18, 2025

    Report

    Report Number
    0001825034-2025-00746
    Event Type
    Injury
    Date Received
    March 18, 2025
    Date of Event
    January 8, 2024
    Report Date
    July 28, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K042757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A2: PATIENT WAS BORN IN (B)(6). D10-MEDICAL PRODUCT: VNGD SSK 360 R FEM 75MM, ITEM#: 185268, LOT#: 2794979, BMT SMOOTH KNEE STEM 18X80, ITEM#: 145028, LOT#: 136580, VG 360 DST FM AG 75X5 LL/RM, ITEM#: 185328, LOT#: 765410, VG 360 DST FM AG 75X10 RL/LM, ITEM#: 185388, LOT#: 966850, VG 360 UNIV PST FM AUG 75X5, ITEM#: 185348, LOT#: 665610, BMT 360 TIB TRAY 71MM, ITEM#: 185203, LOT#: 925800, BIOMET SMOOTH KNEE STEMS 14X40, ITEM#: 145004, LOT#: 608190, BMT 360 TIB 5.0 OFFSET ADAPTER, ITEM#: 185211, LOT#: 102680. G2: UNITED KINGDOM. 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.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE INFORMATION, IT WAS DETERMINED THAT THIS ITEM WAS REPORTED IN ERROR. THERE ARE NO ALLEGATIONS AGAINST THE ARTICULAR SURFACE AS THE REPORTED ISSUE IS FOR BONE FRACTURE ON THE FEMORAL SIDE. PLEASE VOID PREVIOUS REPORT REGARDING THE ARTICULAR SURFACE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT'S LEG WAS AMPUTATED ABOVE THE RIGHT KNEE APPROXIMATELY NINE AND A HALF YEARS POST IMPLANTATION DUE TO INJURIES SUSTAINED IN A FALL RESULTING IN A FRACTURE OF THE RIGHT FEMUR. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE INFORMATION, IT WAS DETERMINED THAT THIS ITEM WAS REPORTED IN ERROR. THERE ARE NO ALLEGATIONS AGAINST THE ARTICULAR SURFACE AS THE REPORTED ISSUE IS FOR BONE FRACTURE ON THE FEMORAL SIDE. PLEASE VOID PREVIOUS REPORT REGARDING THE ARTICULAR SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372300 VNGD SSK PSC TIB BRG 16X63/67 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 282960

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Hospitalization| R SEE H11