BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 VANGUARD CR TIB BRG 71/75X10

    MDR report key: 21882940 · Received April 22, 2025

    Report

    Report Number
    0001825034-2025-01173
    Event Type
    Injury
    Date Received
    April 22, 2025
    Date of Event
    March 27, 2025
    Report Date
    July 28, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCT: VANG CR POR/HA FEM - LT 60: CATALOG#167044, LOT#2987660; POLISHED FINNED TIB TRAY 71MM: CATALOG#141253, LOT#2013100019; SERIES A PAT THN 34 3 PEG: CATALOG#184786, LOT#689620; DEPUY CMW2 GENTAMICIN BONE CEMENT: CATALOG#3325020, LOT#3620321. G2: FOREIGN: AUSTRALIA THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6. THE EVENT IS CONFIRMED. NO DEVICES WERE RETURNED BACK FOR INVESTIGATION. PHOTOGRAPHS OF EXPLANTED DEVICES WERE PROVIDED, AND THE BEARING COMPONENT SHOWS WEAR, AND A SMALL PIECE FRACTURED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. X-RAYS DEMONSTRATED A RIGHT TOTAL KNEE ARTHROPLASTY WITH NARROWING OF THE MEDIAL COMPARTMENT WHICH COULD INDICATE UNDERLYING POLYETHYLENE WEAR. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY ELEVEN (11) YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO WEAR AND BREAKAGE OF THE ARTICULAR SURFACE. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A COMPETITOR KNEE SYSTEM. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN REPORTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261071 E1 VANGUARD CR TIB BRG 71/75X10 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 179660

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention| H SEE H11 NARRATIVE