BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMT SPLINED KNEE STM V2 12X120

    MDR report key: 8498177 · Received April 9, 2019

    Report

    Report Number
    0001825034-2019-01639
    Event Type
    Injury
    Date Received
    April 9, 2019
    Date of Event
    January 30, 2019
    Report Date
    May 10, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    K140883
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO PATIENT'S ANATOMY. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 01663 - 1.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). CONCOMITANT MEDICAL PRODUCTS: VNGD SSK 360 R FEM 60MM: P/N: 185262, L/N: 2873466, BMT SPLINED KNEE STM; P/N: 148315, L/N: 205600. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS AND ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 01663, 0001825034 - 2019 - 01639. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE DUE TO VASCULAR DISEASE APPROXIMATELY SIX YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287695 BMT SPLINED KNEE STM V2 12X120 PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 205600

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R