BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL INLAY IMPACTOR HEAD

    MDR report key: 6517188 · Received April 24, 2017

    Report

    Report Number
    3005738134-2017-00004
    Event Type
    Malfunction
    Date Received
    April 24, 2017
    Date of Event
    March 28, 2017
    Report Date
    July 26, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING AN MAKO IMPACTOR WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: THE DEVICE WAS RETURNED IN USED CONDITION AND SHOWED THE IMPACTOR HEAD WAS FRACTURED. THERE ARE SCRATCHES AND GOUGES ON THE BOTTOM AND SIDES OF THE IMPACTOR. MATERIAL ANALYSIS INDICATED FRACTURE CONSISTENT WITH AN OVERLOAD CONDITION. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS MEDICAL RECORDS WERE NOT RECEIVED AND PATIENT FACTORS DIDN'T CONTRIBUTE TO THE EVENT. DEVICE HISTORY REVIEW: 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 REPORTED EVENT WAS CONFIRMED BY VISUAL INSPECTION WHICH SHOWED THE IMPACTOR HEAD FRACTURED. MATERIAL ANALYSIS INDICATED FRACTURE CONSISTENT WITH AN OVERLOAD CONDITION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION WILL BE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE IMPACTOR TIP PART NUMBER 160177 BROKE AT THE HOSPITAL.

    Description of Event or Problem · 1

    THE IMPACTOR TIP PART NUMBER 160177 BROKE AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296831 TIBIAL INLAY IMPACTOR HEAD PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other