BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS TIBIAL BEARING 10X63/67MM

    MDR report key: 6303278 · Received February 6, 2017

    Report

    Report Number
    0001825034-2017-00462
    Event Type
    Injury
    Date Received
    February 6, 2017
    Date of Event
    December 16, 2014
    Report Date
    June 2, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: BIOMET CC CRUCIATE TRAY 67 MM, PART NUMBER: 141232, LOT NUMBER: J3081691; VANGUARD PS OPEN BOX FEMORAL 55 MM RIGHT-INTERLOK, PART NUMBER: 183100, LOT NUMBER: 323170. THIS REPORT IS 1 OF 3 FOR THIS PATIENT: 0001825034-2017-00460, 0001825034-2017-00461, 0001825034-2017-00462.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING A KNEE ARTHROPLASTY, THE PATIENT IS EXPERIENCING AN UNKNOWN COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86251 VANGUARD PS TIBIAL BEARING 10X63/67MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 503450

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other