BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD SSK 360 FEMUR RIGHT WITH SCREW

    MDR report key: 8444264 · Received March 22, 2019

    Report

    Report Number
    0001825034-2019-01280
    Event Type
    Injury
    Date Received
    March 22, 2019
    Date of Event
    February 25, 2019
    Report Date
    October 17, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT SAMPLE WAS EVALUATED AND DAMAGE ON THE THREADS AND SCREW HEAD WERE IDENTIFIED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - BIOMET 360 TIBIAL CRUCIATE WING CATALOG #: 185650 LOT #: 537650, BIOMET 360 TIBIAL TRAY 67MM CATALOG #: 185202 LOT #: 346840, BIOMET 370 TIBIAL AUGMENT 67MM X 5MM CATALOG #: 185222 LOT #: 185940, BIOMET SPLINED KNEE STEM 12MM X 40MM CATALOG #: 148287 LOT #: 927070, BIOMET 370 TIBIAL OFFSET ADAPTER CATALOG #: 185211 LOT #: 268140, VANGUARD 360 DISTAL FEMORAL AUGMENT 60MM X 10 CATALOG #: 185402 LOT #: 176370, VANGUARD 360 UNIVERSAL POSTERIOR FEMORAL AUGMENT 60MM X 5MM CATALOG #: 185342 LOT #: 248910, SERIES A STANDARD PATELLA 31MM CATALOG #: 184764 LOT #: 490360, BIOMET SPLINED KNEE STEM 10MM X 80MM CATALOG #: 148300 LOT #: 092550, BIOMET 370 2.5MM OFFSET ADAPTER CATALOG #: 185210 LOT #: 037280, VANGUARD 370 DISTAL FEMORAL AUGMENT 60MM X 10MM CATALOG #: 185382 LOT #: 347080, VANGUARD SSK TIBIAL BEARING 12MM X 63/67MM CATALOG #: 185062 LOT #: 003150. THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS THE MIGRATION OF THE FEMORAL SCREW THAT WAS FLOATING FREELY IN THE JOINT APPROXIMATELY SIX (6) MONTHS POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236003 VANGUARD SSK 360 FEMUR RIGHT WITH SCREW PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 6039463

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R