BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOMET VANGUARD TIBIAL TRAY

    MDR report key: 6786941 · Received August 10, 2017

    Report

    Report Number
    0001825034-2017-06179
    Event Type
    Injury
    Date Received
    August 10, 2017
    Date of Event
    October 31, 2016
    Report Date
    August 9, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PNI
    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 MEDICAL PRODUCTS: MEDICAL PRODUCT: UNKNOWN VANGUARD BEARING, CATALOG # UNKNOWN LOT # UNKNOWN UNKNOWN VANGUARD FEMORAL COMPONENT, CATALOG # UNKNOWN LOT # UNKNOWN, UNKNOWN VANGUARD PATELLA, CATALOG # UNKNOWN LOT # UNKNOWN. INITIAL REPORTER: Z. C. LUM, A. V. LOMBARDI, J. M. HURST, M. J. MORRIS, J. B. ADAMS, K. R. BEREND FROM JOINT IMPLANT SURGEONS, INC., OHIO, UNITED STATES ¿EARLY OUTCOMES OF TWIN-PEG MOBILE-BEARING UNICOMPARTMENTAL KNEE ARTHROPLASTY COMPARED WITH PRIMARY TOTAL KNEE ARTHROPLASTY¿ VOLUME 98-B NUMBER 10, OCTOBER 2016. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED,A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS ARE UNKNOWN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-06177, 0001825034-2017-06178, 0001825034-2017-06180.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT ONE (1) PATIENT UNDERWENT AN INCISION AND DEBRIDEMENT PROCEDURE FOR WOUND DEHISCENCE. NO ADDITIONAL PATIENT CONSEQUENCE WAS REPORTED. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564048 UNKNOWN BIOMET VANGUARD TIBIAL TRAY PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R