BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAN INSERT ONLAY SZ 7

    MDR report key: 7408562 · Received April 9, 2018

    Report

    Report Number
    0002249697-2018-01057
    Event Type
    Injury
    Date Received
    April 9, 2018
    Date of Event
    March 14, 2018
    Report Date
    April 9, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK FEMORAL-RM-LL-SZ 6 180516 26090912-01, MCK TIBIAL BASEPLATE-RM/LL-SZ 7 180617 26290612-01. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. NOT RETURNED.

    Description of Event or Problem · 1

    PATIENT HAD A MAKO RIGHT MEDIAL UNI KNEE DONE (B)(6) 2014. HE CLAIMS THAT HE HAD CONTINUED PAIN FROM THE BEGINNING. HE SAW SURGEON FOR FOLLOW UP AND REQUESTED A CONVERSION TO A TOTAL. HE WAS SCHEDULED FOR OPERATION ON (B)(6) 2018. THE MAKO COMPONENTS WERE REMOVED AND REPLACED WITH A TRITHLON TOTAL KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249927 TIBIAN INSERT ONLAY SZ 7 PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 12041012-1

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R