BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-RT 67.5

    MDR report key: 7843679 · Received September 4, 2018

    Report

    Report Number
    0001825034-2018-08680
    Event Type
    Injury
    Date Received
    September 4, 2018
    Date of Event
    August 8, 2018
    Report Date
    May 9, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 08683 - 1. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN, (B)(6). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 183460, VNGD CR TIB BRG 10X79/83, LOT #: 844060. CATALOG #: 141255, POLISHED FINNED TIB TRAY 79MM, LOT # 2014100861. CATALOG #: 66017569, PALACOS R+G 2X40, LOT # 79834406. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 08683. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND 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 HAS BEEN REPORTED BY THE PATIENTS LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT A RIGHT KNEE REPLACEMENT ON UNKNOWN DATE. THE PATIENT IS REPORTING ALLEGED INJURY FROM THE ALLEGED FAILURE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683720 VANGUARD CR ILOK FEM-RT 67.5 KNEE, PROSTHESIS JWH ZIMMER BIOMET, INC. N/A 184560

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R .| .