BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET 360 TIBIAL AUGMENT WITH BOLTS

    MDR report key: 6943884 · Received October 12, 2017

    Report

    Report Number
    0001825034-2017-08487
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    June 6, 2017
    Report Date
    October 12, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) MEDICAL PRODUCT - BMT SPLINED KNEE STM V2 18X40, CAT#: 148293 LOT#: 818780; BMT 360 TIB AUG 83X5MM, CAT#: 185226 LOT#: 304860 ; BMT 360 TIB TRAY 83MM, CAT#: 185206 LOT#: 952960 ; BMT 360 TIB LG CRUCIATE WING, CAT#: 185651 LOT#: 790440 ; BMT 360 TIB 5.0 OFFSET ADAPTER, CAT#: 185211 LOT#: 874310 ; E1 VNGD PS+ TIB BRG 79/83X16, CAT#: EP-183766 LOT#: 111750 ; VAN PS OPEN INTL FEM-LT 70 CAT#. 183132 LOT#. 442030. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THE RISK FOR THE REPORTED ISSUE IS ADDRESSED IN I/O RISK TABLE. 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 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 04596, 0001825034 - 2017 - 08486 , 0001825034 - 2017 - 08488 , 0001825034 - 2017 - 08489, 0001825034 - 2017 - 08494 , 0001825034 - 2017 - 08495.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED TO ADDRESS FEMORAL COMPONENT LOOSENING. FURTHER REVIEW OF THE PROVIDED PATIENT'S X-RAYS DETERMINED THAT RADIOLUCENCY IS ALSO PRESENT AT TIBIAL IMPLANT CEMENT-BONE AND METAL-BONE INTERFACES CONSISTENT WITH LOOSENING. ADDITIONALLY, THE TIBIAL TRAY IS NOT PERPENDICULAR TO THE LONG AXIS OF THE TIBIA ON THE AP VIEW AND RATHER EXHIBITS SEVERAL DEGREES TILT WITH SUGGESTION OF SUBSIDENCE OF THE MEDIAL TIBIAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724003 BIOMET 360 TIBIAL AUGMENT WITH BOLTS PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 059760

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R