BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD CR TIB BRG

    MDR report key: 16852542 · Received May 2, 2023

    Report

    Report Number
    0001825034-2023-00930
    Event Type
    Injury
    Date Received
    May 2, 2023
    Date of Event
    April 11, 2023
    Report Date
    May 19, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    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

    (B)(4). D11: MEDICAL DEVICE: VANGUARD CR ILOK FEM-LT 65 ITEM # 183028 LOT # 098640, POLISHED FINNED TIB TRAY 71MM ITEM # 141253 LOT # 2013101562, PALACOS R + G (1X40) ITEM # 66022663 LOT # 77794358. G2: AUSTRALIA. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE REQUESTED BUT NOT RETURNED BY HOSPITAL. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. H3 OTHER TEXT : NOT RETURNED BY HOSPITAL.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. MEDICAL RECORDS REVIEW INDICATES NO COMPLICATION DURING SURGERY. NO OTHER INFORMATION WAS PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE NINE YEARS POST IMPLANTATION DUE TO INSTABILITY. ARTICULAR SURFACE PROSTHESIS WAS EXCHANGED WITHOUT ISSUES ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162983 VNGD CR TIB BRG PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 380150

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H