BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS TIBIAL BEARING

    MDR report key: 6869919 · Received September 15, 2017

    Report

    Report Number
    0001825034-2017-07007
    Event Type
    Injury
    Date Received
    September 15, 2017
    Date of Event
    September 19, 2017
    Report Date
    December 1, 2017
    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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIVING ADDITIONAL INFORMATION ON THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THE PATIENT WAS REVISED DUE TO FEMORAL LOOSENING. EVENT WILL BE REPORTED UNDER MFR 0001825034-2017-07121.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: VANGUARD PS OPEN BOX FEMORAL, CAT#: 183126 LOT#: 397720, BIOMET TIBIAL TRAYS, CAT#: 141234 LOT#: J2746565, BIOMET SERIES STANDARD PATELLA, CAT#: 184762 LOT#: 848060. THE COMPLAINT DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE REPORTS 0001825034-2017-07007, 0001825034-2017-07121, 0001825034-2017-07126, 0001825034-2017-07127.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 PROCEDURE AND SUBSEQUENTLY EXPERIENCED PAIN IMMEDIATELY POST-OPERATIVE. PATIENT IS BEING SCHEDULED FOR A REVISION DUE TO PAIN AND SLIPPAGE OF DEVICE.

    Description of Event or Problem · 1

    IT IS NOW REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649231 VANGUARD PS TIBIAL BEARING PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 031570

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention| S