BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD TIBIAL BEARING

    MDR report key: 7866157 · Received September 11, 2018

    Report

    Report Number
    0001825034-2018-08855
    Event Type
    Injury
    Date Received
    September 11, 2018
    Report Date
    September 13, 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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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: VANGUARD TIBIAL BEARING, CAT#: 183642, LOT#: 972670; BIOMET CC TRAY, CAT#: 141233, LOT#: J3775869; VANGUARD PS OPEN FEMUR, CAT#: 183112, LOT#: 923840; VANGUARD KNEE SERIES A STANDARD PATELLA, CAT#: 184766, LOT#: 189420. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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: 0001825034-2018-04472, 0001825034-2018-08855, 0001825034-2018-08856, 0001825034-2018-08857. PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT IS EXPERIENCING PAIN, SWELLING, LIMITED RANGE OF MOTION AND AN ALLERGIC REACTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706826 VANGUARD TIBIAL BEARING PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 972670

    Patients

    Seq Age Sex Outcome Treatment
    1 Other