BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD PS TIB BRG 10X63/67MM

    MDR report key: 9087935 · Received September 19, 2019

    Report

    Report Number
    0001825034-2019-04197
    Event Type
    Injury
    Date Received
    September 19, 2019
    Date of Event
    February 28, 2017
    Report Date
    February 25, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    OFFICE NOTES PROVIDED CONFIRM THE PATIENT WAS EXPERIENCING PAIN AND UNDERWENT MANIPULATION UNDER ANESTHESIA. NO DEVICES OR PHOTOS 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. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD FEMORAL LEFT, CATALOG 183128, LOT J3721221; BIOMET CRUCIATE TRAY 63MM, CATALOG 141231, LOT J3734099; VANGUARD FEMORAL PEGS SET 2, CATALOG 183099, LOT 0827330; SERIES A STANDARD 3 PEG PATELLA, 184762, LOT 818530; PALACOS R 1X40 BONE CEMENT, CATALOG 00111214001, LOT 83264474. CUSTOMER HAS NOT INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 THE PATIENT WAS EXPERIENCING PAIN AND STIFFNESS AND SUBSEQUENTLY UNDERWENT A MANIPULATION UNDER ANESTHESIA APPROXIMATELY SIX MONTHS POST LEFT KNEE ARTHROPLASTY DUE TO ARTHROFIBROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883593 VNGD PS TIB BRG 10X63/67MM PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 826490

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R