BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR POR FMRL-LT 65

    MDR report key: 7753159 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-05926
    Event Type
    Injury
    Date Received
    August 6, 2018
    Date of Event
    December 4, 2018
    Report Date
    May 17, 2019
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO PATIENT CONDITION. 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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT IS EXPERIENCING PAIN AND SWELLING. PATIENT HAS TESTED POSITIVE FOR A NICKEL ALLERGY. PATIENT HAS NOW BEEN REVISED.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS: BMET REGENX PRI TIB TRAY 71MM CATALOG#: 141273; LOT#: 740750, MODULAR SPLINED STEM 40MM CATALOG#: 141369; LOT#: 300080, VNGD ANT STBLZD BRG 10X71 CATALOG#: 189060; LOT#: 982920. THE PRODUCT CANNOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT IS EXPERIENCING PAIN AND SWELLING. PATIENT HAS TESTED POSITIVE FOR A NICKEL ALLERGY. NO REVISION PROCEDURE HAS BEEN PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593092 VANGUARD CR POR FMRL-LT 65 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 834170

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention