BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VANGUARD TIBIAL TRAYS

    MDR report key: 6657926 · Received June 21, 2017

    Report

    Report Number
    0001825034-2017-04197
    Event Type
    Injury
    Date Received
    June 21, 2017
    Report Date
    June 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BOVE M, DE FILIPPIS R, RUGGERI A, PERSIANI P, CALISTRI A, VILLANI C. ANTERIOR PAIN FOLLOWING KNEE ARTHROPROSTHESIS. A COMPARISON BETWEEN TWO DIFFERENT CAPSULELIGAMENTOUS SUTURING TECHNIQUES, JOURNAL OF ORTHOPAEDICS AND TRAUMATOLOGY (2014), 10.1007/S10195-014-0314-Y. 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 ITEM AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE ITEM AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS 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: 0001825034-2017-04197, 0001825034-2017-04201, 0001825034-2017-04204.

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE IT WAS REPORTED THAT 2 PATIENTS EXPERIENCED EXTERNAL HYPER-PRESSION AND PAIN DURING THE FIRST MONTHS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437406 UNKNOWN VANGUARD TIBIAL TRAYS PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention KNE-VANGUARD-BEARINGS-UNK| KNE-VANGUARD-FEMORALS-UNK