BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD BMT 360 TIB LG CRUCIATE WING

    MDR report key: 12237908 · Received July 28, 2021

    Report

    Report Number
    0001825034-2021-02191
    Event Type
    Injury
    Date Received
    July 28, 2021
    Date of Event
    July 1, 2021
    Report Date
    November 30, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304525764
    PMA / PMN Number
    K140883
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS IDENTIFIED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. PLEASE VOID REPORT.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS IDENTIFIED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. PLEASE VOID REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT DEVICES -SERIES A PAT THIN 37X8.6 3 PEG CATALOG #: 184788 LOT #: 290860; BMT SPLINED KNEE STM 14X80 CATALOG #: 141614 LOT #: 263030; BMT 360 TIB 5.0 OFFSET ADAPTER CATALOG #: 185211 LOT #: 162500; VNGD ANT STBLZD BRG 12X75 CATALOG #: 189082 LOT #: 581300 REPORT SOURCE - FOREIGN: (B)(6). THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS NOT RETURNED, BECAUSE OF HOSPITAL POLICY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ACCORDING TO THE SURGEON, THE KNEE WAS UNSTABLE WITH TIBIAL COMPONENTS SHOWING INCREASED HOT SPOTS IN A SCAN. PATIENT WAS REVISED DUE TO THE INSTABILITY. ATTEMPTS HAVE BEEN MADE, BUT THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133182 VANGUARD BMT 360 TIB LG CRUCIATE WING PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 711840 00880304525764

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| R SEE H10 NARRATIVE.