BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR TIBIAL BEARING 14X63/67

    MDR report key: 7765575 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-07407
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    October 12, 2006
    Report Date
    August 8, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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 CONTRIBUTE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT PRIMARY LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT UNDERWENT REVISION OF POLY COMPONENT, LRR AND PATELLAR DENERVATION DUE TO SEVERE PAIN APPROXIMATELY 17 MONTHS POST-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601952 VANGUARD CR TIBIAL BEARING 14X63/67 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R