BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL INSERT ONLAY TRIAL-SIZE 6-8MM

    MDR report key: 6153186 · Received December 7, 2016

    Report

    Report Number
    3005985723-2016-00423
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 23, 2016
    Report Date
    December 28, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DAMAGE INVOLVING A MAKO TRIAL WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION OF RETURNED DEVICE INDICATED THAT DEVICE IS RETURNED IN USED CONDITION AND DAMAGES WERE OBSERVED THROUGHOUT THE DEVICE. EXAMINATION OF DEVICE BY A MATERIAL ANALYST ENGINEER INDICATED THE DAMAGE IS CONSISTENT WITH EXPLANT DAMAGE. NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. THERE HAS BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IT WAS REPORTED THAT POLY INSERT TRIAL BECAME DAMAGED DURING REMOVAL FROM THE JOINT. VISUAL INSPECTION OF RETURNED DEVICE CONFIRMED THE EVENT WHICH INDICATED THAT DEVICE IS RETURNED IN USED CONDITION AND DAMAGES WERE OBSERVED THROUGHOUT THE DEVICE. EXAMINATION OF DEVICE BY A MATERIAL ANALYST ENGINEER INDICATED THE DAMAGE IS CONSISTENT WITH EXPLANT DAMAGE. IF THE ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE SIZE 6X8MM POLY TRIAL INSERT AT GLASTONBURY SURGICAL CENTER BECAME DAMAGED DURING REMOVAL. POLY INSERT TRIAL BECAME DAMAGED DURING REMOVAL FROM THE JOINT. THE PLASTIC NO LONGER CORRECTLY SITS ON BASEPLATE DUE TO MISSHAPEN STATE.

    Description of Event or Problem · 1

    THE SIZE 6X8MM POLY TRIAL INSERT AT GLASTONBURY SURGICAL CENTER BECAME DAMAGED DURING REMOVAL. POLY INSERT TRIAL BECAME DAMAGED DURING REMOVAL FROM THE JOINT. THE PLASTIC NO LONGER CORRECTLY SITS ON BASEPLATE DUE TO MISSHAPEN STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801249 TIBIAL INSERT ONLAY TRIAL-SIZE 6-8MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 12420515

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other