BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK TIBIAL BASEPLATE-RM/LL-SZ 7

    MDR report key: 8687278 · Received June 11, 2019

    Report

    Report Number
    3005985723-2019-00420
    Event Type
    Injury
    Date Received
    June 11, 2019
    Date of Event
    May 14, 2019
    Report Date
    June 11, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    UDI-DI
    00848486000806
    PMA / PMN Number
    K090763
    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 TIBIAL ONLAY INSERT-SZ 7-8MM; CAT# 180707-1; LOT# 12010316-1. MCK FEMORAL-RM-LL-SZ 7; CAT# 180517; LOT# 2561201-1. 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 DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    GOT A TEXT FROM SURGEON WITH PICTURE OF WHAT APPEARS TO BE A CRACK IN THE MAKO TIBIAL BASEPLATE. UPDATE 15/MAY/2019: AS REPORTED IN PRODUCT NOT AVAILABLE - WHY NOT: "STILL IN PATIENT". UPDATE: NO PLAN FOR REVISION AT THIS TIME. PATIENT REPORTED KNEE PAIN. KNEE IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481770 MCK TIBIAL BASEPLATE-RM/LL-SZ 7 PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 26210516-01 00848486000806

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other