BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK TIBIAL ONLAY INSERT-SZ 3-8MM

    MDR report key: 6859385 · Received September 12, 2017

    Report

    Report Number
    3005985723-2017-00432
    Event Type
    Injury
    Date Received
    September 12, 2017
    Date of Event
    August 15, 2017
    Report Date
    September 12, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    UDI-DI
    00848486000851
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK PATELLA RESURFACING ROUND DOME-32 MM; CAT# 180320-3; LOT# 12370715-1. MCK PATELLOFEMORAL-R-SZ 2; CAT# 180412; LOT# 467482-M. MCK FEMORAL-RM-LL-SZ 2; CAT# 180512; LOT# 464706-M. MCK TIBIAL BASEPLATE-RM/LL-SZ 3; CAT# 180613; LOT# 26371016-01. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. REVIEW OF THE PRODUCT HISTORY RECORDS INDICATES PRODUCTS WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE STERILE 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

    IT WAS REPORTED THAT THE SURGEON PERFORMED A POLY EXCHANGE OF A PATIENT'S RIGHT KNEE DUE TO POSSIBLE INFECTION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638707 MCK TIBIAL ONLAY INSERT-SZ 3-8MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY NPJ MAKO SURGICAL CORP. 12401015-1 00848486000851

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R