BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK PATELLA RESURFACING ROUND DOME-35MM

    MDR report key: 5075483 · Received September 14, 2015

    Report

    Report Number
    3005985723-2015-00161
    Event Type
    Injury
    Date Received
    September 14, 2015
    Date of Event
    June 16, 2015
    Report Date
    August 18, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INSTABILITY INVOLVING A MAKO PATELLA 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. -MEDICAL RECORDS RECEIVED AND EVALUATION: THE PROVIDED MEDICAL RECORDS WERE REVIEWED BY A CONSULTING CLINICIAN WHO INDICATED BASED UPON THE INFORMATION AVAILABLE FOR REVIEW, NO DETERMINATION CAN BE MADE REGARDING THE PAINFUL, UNSTABLE PATELLAR TRACKING IN THIS CASE. -DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES -COMPLAINT HISTORY REVIEW: THERE HAS BEEN NO OTHER EVENT FOR THE LOT REFERENCED. 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.

    Description of Event or Problem · 1

    PATIENT IS COMPLAINING OF UNSTABLE AND SOMETIMES PAINFUL PATELLA/PATELLA TRACKING. RIGHT MEDIAL BICOMP PROCEDURE WAS SUCCESSFULLY COMPLETED ON JUNE 16, 2014. NO PATELLA ISSUES WERE NOTED DURING SURGERY.

    Description of Event or Problem · 1

    PATIENT IS COMPLAINING OF UNSTABLE AND SOMETIMES PAINFUL PATELLA/PATELLA TRACKING. RIGHT MEDIAL BICOMP PROCEDURE WAS SUCCESSFULLY COMPLETED ON JUNE 16, 2014. NO PATELLA ISSUES WERE NOTED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605088 MCK PATELLA RESURFACING ROUND DOME-35MM IMPLANT NPJ MAKO SURGICAL CORP. 12040711-3

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other