BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD SSK PS TIB BRG 20X79/83

    MDR report key: 7048409 · Received November 21, 2017

    Report

    Report Number
    0001825034-2017-10446
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    December 1, 2015
    Report Date
    November 21, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK042757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: BIOMET SSK 360 FEMORAL, CAT#: 185267, LOT#: 3458058. BIOMET 360 TIBIAL TRAY, CAT#: 185205 LOT#: 543990. BIOMET 360 TIBIAL CRUCIATE WING, CAT#: 185651 LOT#: 727980. BIOMET 360 TIBIAL OFFSET ADAPTER, CAT#: 185211 LOT#: 970140. BIOMET SPLINED KNEE STEM, CAT#: 141620 LOT#: 481350. BIOMET SPLINED KNEE V2 STEM, CAT#: 148295 LOT#: 631690. VANGUARD DISTAL FEMORAL AUGMENT, CAT#: 185387 LOT#: 002200. VANGUARD DISTAL FEMORAL AUGMENT, CAT#: 185407 LOT#: 304400. BIOMET OFFSET ADAPTER CAT#:185211 LOT#: 970140. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-07374, 0001825034-2017-07375, 0001825034-2017-07386, 0001825034-2017-07387, 0001825034-2017-07388, 0001825034-2017-07389, 0001825034-2017-07390, 0001825034-2017-07391, 0001825034-2017-07392. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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 THE PATIENT WAS SCHEDULED TO BE REVISED DUE TO PAIN. IT WAS NOTED THAT THE PATIENT HAD CANCELLED THE OPERATION AND WAS DISCHARGED DUE TO FAILURE TO COMPLY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830500 VNGD SSK PS TIB BRG 20X79/83 KNEE, PROSTHESIS JWH ZIMMER BIOMET, INC. 624650

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention