BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS OPEN INTL FEM-LT 65

    MDR report key: 19911496 · Received August 5, 2024

    Report

    Report Number
    0001825034-2024-01976
    Event Type
    Injury
    Date Received
    August 5, 2024
    Date of Event
    July 18, 2024
    Report Date
    December 31, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304270909
    PMA / PMN Number
    K113550
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 183640 - VNGD PS TIB BRG 10X71/75MM - 895700 141254 - POLISHED FINNED TIB TRAY 75MM - 2018070516 184768 - SERIES A PAT STD 37 3 PEG - 218360 66056768 - PALACOS R+G FAST - 95434929 66056768 - PALACOS R+G FAST - 95434929 G2 : FOREIGN COUNTRY : AUSTRALIA 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6 : MECHANICAL (G04) - FEMUR. VISUAL EXAMINATION OF THE PROVIDED PICTURE IDENTIFIED AN EXPLANTED FEMORAL IMPLANT IS BIO-DEBRIS AND FOREIGN MATERIAL STILL ATTACHED TO THE IMPLANT. AS THE DEVICE WAS NOT RETURNED FURTHER EVALUATIONS COULD NOT BE PERFORMED. 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 BUT NOT REVIEWED AS IT WAS DETERMINED THE RADIOGRAPHS ARE UNDATED AND ALL IMAGES CONTAIN FEMORAL PLATING BEYOND EXPECTED KNEE COMPONENTS SO TIMELINE OF IMAGES IS ULTIMATELY UNCLEAR. 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 A PATIENT UNDERWENT AN INITIAL KNEE SURGERY. APPROXIMATELY 3.5 YEARS POST-OP, THE PATIENT WAS REVISED DUE TO A PERIPROSTHETIC FRACTURE OF THE DISTAL FEMUR. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    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
    2028198 VANGUARD PS OPEN INTL FEM-LT 65 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J3864000 00880304270909

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11.