BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD (TM) DCM PS TIBIAL BEARING

    MDR report key: 7103065 · Received December 10, 2017

    Report

    Report Number
    0001825034-2017-11036
    Event Type
    Injury
    Date Received
    December 10, 2017
    Date of Event
    November 20, 2017
    Report Date
    September 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW, HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VNGD PS OPEN INTL FEM-RT 57.5 CATALOG # 183102 LOT # 492180, BIOMET CC CRUCIATE TRAY 63MM CATALOG # 141231 LOT # 084080, BMET ARCOM AP PAT W/WIRE 28MM CATALOG # 11-150825 LOT # 958020. PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET. 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 PATIENT UNDERWENT RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882027 VANGUARD (TM) DCM PS TIBIAL BEARING PROSTHHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 005910

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R