BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIA INST-VITAMIN E-ONLAY SIZE5-8MM

    MDR report key: 6591508 · Received May 25, 2017

    Report

    Report Number
    3005985723-2017-00231
    Event Type
    Injury
    Date Received
    May 25, 2017
    Date of Event
    April 27, 2017
    Report Date
    May 25, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K133039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK FEMORAL-RM-LL-SZ 5; CAT# 180515; LOT# 26070415, MCK TIBIAL BASEPLATE-RM/LL-SZ 5; CAT# 180615; LOT# 32031015. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    SALES REP REPORTED A REVISION OF RIGHT KNEE DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372376 TIBIA INST-VITAMIN E-ONLAY SIZE5-8MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 12110913-1

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R