BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PS OPEN BOX FEMORAL

    MDR report key: 6694457 · Received July 7, 2017

    Report

    Report Number
    0001825034-2017-04596
    Event Type
    Injury
    Date Received
    July 7, 2017
    Date of Event
    June 6, 2017
    Report Date
    October 11, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IMPLANT DATE UNKNOWN. IT WAS NOTED THERE WERE SCRATCHES AND SCUFF MARKS ON THE CONDYLES AND PRESENCE OF BONE CEMENT ON THE PROXIMAL SURFACE OF THE FEMORAL COMPONENT. THE FEMORAL COMPONENT WAS DIMENSIONALLY INSPECTED AND FOUND TO BE CONFORMING TO THE PRINT. 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.

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT MEDICAL PRODUCT: BMT SPLINED KNEE STM V2 18X40, CAT#: 148293 LOT#: 818780; BMT 360 TIB AUG 83X5MM, CAT#: 185226 LOT#: 059760; 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. PRODUCT HAS BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 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.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS FEMORAL COMPONENT LOOSENING. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473110 VANGUARD PS OPEN BOX FEMORAL PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 442030

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R