BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK TIBIAL ONLAY INSERT-SZ 2-9MM

    MDR report key: 4922397 · Received July 17, 2015

    Report

    Report Number
    3005985723-2015-00125
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    June 24, 2015
    Report Date
    June 24, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ALLEGED SEATING ISSUES INVOLVING A MAKO INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: NO PATIENT MEDICAL RECORDS WERE AVAILABLE FOR REVIEW. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER

    Description of Event or Problem · 1

    DR. (B)(6) PERFORMED A (B)(4) MAKO SURGERY ON (B)(6) 2015. HE NOTICED THE NEXT DAY FROM THE X-RAY THAT IT APPEARED THE TIBIAL INSERT WAS NOT SEATED CORRECTLY. HE DECIDED HE WOULD PERFORM A POLY EXCHANGE ON (B)(6). HE OPENED WOUND, SAW THE INSERT WAS NOT LOCKED IN THE POSTERIOR. HE REMOVED THAT INSERT AND PUT ANOTHER IN. HE SAID HE THOUGHT IT LOOKED SEATED ORIGINALLY BUT DUE TO THE PATIENT'S SMALL ANATOMY HE WAS UNABLE TO SEE THE POSTERIOR WELL. HE TOOK EXTRA CARE TO MAKE SURE THE SECOND ONE WAS SEATED CORRECTLY AND WAS HAPPY WITH THE OUTCOME. HE SAID THE PATIENT WAS VERY UNDERSTANDING.

    Description of Event or Problem · 1

    DR. (B)(6) PERFORMED A UKA MAKO SURGERY ON (B)(6) 2015. HE NOTICED THE NEXT DAY FROM THE X-RAY THAT IT APPEARED THE TIBIAL INSERT WAS NOT SEATED CORRECTLY. HE DECIDED HE WOULD PERFORM A POLY EXCHANGE ON (B)(6). HE OPENED WOUND, SAW THE INSERT WAS NOT LOCKED IN THE POSTERIOR. HE REMOVED THAT INSERT AND PUT ANOTHER IN. HE SAID HE THOUGHT IT LOOKED SEATED ORIGINALLY BUT DUE TO THE PATIENT'S SMALL ANATOMY HE WAS UNABLE TO SEE THE POSTERIOR WELL. HE TOOK EXTRA CARE TO MAKE SURE THE SECOND ONE WAS SEATED CORRECTLY AND WAS HAPPY WITH THE OUTCOME. HE SAID THE PATIENT WAS VERY UNDERSTANDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465272 MCK TIBIAL ONLAY INSERT-SZ 2-9MM IMPLANT NPJ MAKO SURGICAL CORP. 12021113-2

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention