BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD E1 TIBIAL BEARING 10MMX67MM

    MDR report key: 7751274 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-05881
    Event Type
    Injury
    Date Received
    August 6, 2018
    Date of Event
    September 18, 2014
    Report Date
    August 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT DEVICES: VANGUARD CRUCIATE RETAINING INTERLOK FEMORAL COMPONENT LEFT 57.5, CATALOG #: 183022,LOT #: NI; BIOMET CC I-BEAM TIBIAL TRAY 67MM, CATALOG #: 141222, LOT #: NI; SERIES A STANDARD 3-PEG PATELLA 31MM, CATALOG #: 184764, LOT #:. IT IS INDICATED BY THE COMPLAINANT THAT THE DEVICES WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICES REMAIN IMPLANTED. THE COMPLAINT SAMPLE WAS NOT EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-05880. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION OF THE LEFT KNEE TO TREAT UNKNOWN COMPLICATIONS TWO (2) MONTHS FOLLOWING KNEE ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594965 VANGUARD E1 TIBIAL BEARING 10MMX67MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R