BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SPLINED KNEE STEM V2 WITH SCREW

    MDR report key: 8509975 · Received April 12, 2019

    Report

    Report Number
    0001825034-2019-01700
    Event Type
    Injury
    Date Received
    April 12, 2019
    Date of Event
    August 23, 2013
    Report Date
    December 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K121149
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 RELEVANT TO THE REPORTED EVENT 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD 360 FEMORAL AUGEMENT, CATALOG #: 185304, LOT #: 488720. SERIES A PATELLA, CATALOG #: 184766, LOT #: 085270. BIOMET 360 TIBIAL AUGEMENT, CATALOG #: 185223, LOT #: 591280. BIOMET SPLINED KNEE STEM, CATALOG #: 148319, LOT #: 750680. BIOMET SPLINED KNEE STEM, CATALOG #: UNK, LOT #: UNK. VANGUARD SSK TIBIAL BEARING, CATALOG #: 183890, LOT #: 453420. BIOMET 360 OFFSET ADAPTER, CATALOG #: 185210, LOT #: 195020. VANGUARD 360 TIBIAL TRAY, CATALOG #: UNK, LOT #: UNK. BIOMET 360 TIBIAL OFFSET ADAPTER, CATALOG #: 185211, LOT #: 180930. BIOMET 360 TAPER SCREW, CATALOG #: 185213, LOT #: 014910. VANGUARD 360 AUGMENT, CATALOG #: 185424, LOT#: 009030. VANGUARD SSK 360 FEMORAL, CATALOG #: 185284, LOT #: 2780388. BIOMET UNKNOWN CEMENT, CATALOG #: UNK, LOT #: UNK. IT IS UNKNOWN WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE FILED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-01697, 0001825034-2019-01698, 0001825034-2019-01699, 0001825034-2019-01701, 0001825034-2019-01702, 0001825034-2019-01703, 0001825034-2019-01705, 0001825034-2019-01706, 0001825034-2019-01707, 0001825034-2019-01709, 0001825034-2019-01710. 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. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT TOTAL KNEE PROCEDURE. SUBSEQUENTLY, PATIENT IS EXPERIENCING CONTINUED PAIN, LIMPING, UNABLE TO WALK LONG DISTANCES OR FOR EXTENDED TIME FRAME, UNABLE TO KNEEL, USES STAIRS WITH DIFFICULTY, AND USES CRUTCHES OR WALKER TO AMBULATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303802 BIOMET SPLINED KNEE STEM V2 WITH SCREW PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 750680

    Patients

    Seq Age Sex Outcome Treatment
    1 Other