BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEM-LT 67.5

    MDR report key: 8537302 · Received April 22, 2019

    Report

    Report Number
    0001825034-2019-01750
    Event Type
    Injury
    Date Received
    April 22, 2019
    Report Date
    November 21, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: THERAPY DATE: UNKNOWN 141216 - BIOMET ILOK PRI TIB TRAY ¿ 364920, 141316 - BIOMET FINNED PRI STEM - 320740, 11-150830 - BMET ARCOM AP PAT ¿ 978630, EP-189122 - E1 VNGD AS TIB BRG - 310680. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. 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 - 01751, 0001825034 - 2019 - 01752.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT BEGAN EXPERIENCING PAIN, SWELLING, AND SKIN ISSUES AROUND THE IMPLANT SITE DUE TO A POSSIBLE METAL ALLERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328419 VANGUARD CR ILOK FEM-LT 67.5 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J6249508

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other