BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD POSTERIOR STABILIZED OPEN BOX FEMORAL COMPONENT LEFT 65MM

    MDR report key: 8818451 · Received July 23, 2019

    Report

    Report Number
    0001825034-2019-03173
    Event Type
    Injury
    Date Received
    July 23, 2019
    Report Date
    August 27, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS IDENTIFIED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THIS COMPLAINT IS BEING REPORTED UNDER 0001825034-2019-03172.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES ¿ VANGUARD POSTERIOR STABILIZED E1 ANTIOXIDANT INFUSED TIBIAL BEARING 14MM X 71/75MM, CATALOG #: EP-183744, LOT #: 356330; BIOMET MODULAR FINNED STEM WITH SCREW 80MM, CATALOG #: 141318, LOT #: 951040, REGENEREX PRIMARY TIBIAL TRAY WITH LOCKING BAR 71MM, CATALOG #: 141273, LOT #: 590690, REGENEREX SERIES A 3 PEG PATELLA 31MM CATALOG #: 141356, LOT #: 561780. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICES REMAIN IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT. 001825034-2019-03169, 001825034-2019-03170, 001825034-2019-03171, 001825034-2019-03172. INVESTIGATION INCOMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS ALLEGING HARM CAUSED BY THE DEVICE FOLLOWING KNEE ARTHROPLASTY; HOWEVER THE NATURE OF THE HARM IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609636 VANGUARD POSTERIOR STABILIZED OPEN BOX FEMORAL COMPONENT LEFT 65MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 097110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other