BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD SERIES A PAT THIN 37X8.6 3 PEG

    MDR report key: 24498410 · Received March 3, 2026

    Report

    Report Number
    0001825034-2026-00489
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    January 28, 2025
    Report Date
    March 3, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00887868344169
    PMA / PMN Number
    K171054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D10: 183014 - VANGUARD CR ILOK FEM-RT 75 - (B)(6), 189120 - VNGD ANT STBLZD BRG 10X83 - (B)(6), 141236 - BIOMET CC CRUCIATE TRAY 83MM - (B)(6), 110035368 - BIOMET BC R 1X40 US - (B)(6), 110035368 - BIOMET BC R 1X40 US - (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 1 MONTH POST-OP, THE PATIENT PRESENTED WITH PAIN, SWELLING, INSTABILITY, AND INCREASING PATELLA ALTA. THE PATIENT UNDERWENT PATELLAR TENDON REPAIR DUE TO INFERIOR POLE RUPTURE. AFTERWARD, THE CERCLAGE WIRE FAILED RESULTING IN AN ADDITIONAL REPAIR WHICH AGAIN FAILED. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION DUE TO PAIN, SWELLING, FLEXION CONTRACTURE, AND CHRONIC PATELLAR TENDON RUPTURE. DURING THE REVISION, THE INITIAL TIBIAL AND REVISED PATELLAR IMPLANTS WERE RETAINED. THE BEARING AND FEMORAL COMPONENTS WERE REVISED AND AN EXTENSOR MECHANISM ALLOGRAFT RECONSTRUCTION COMPLETED WITHOUT COMPLICATIONS. THE PATIENT DEMONSTRATED SATISFACTORY PROGRESS WITH STRENGTH AND AMBULATION WITH NO FURTHER COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562930 VANGUARD SERIES A PAT THIN 37X8.6 3 PEG PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 371030 00887868344169

    Patients

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