BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL INLAY IMPACTOR HEAD

    MDR report key: 6227464 · Received January 5, 2017

    Report

    Report Number
    3005985723-2017-00003
    Event Type
    Malfunction
    Date Received
    January 5, 2017
    Date of Event
    December 6, 2016
    Report Date
    March 7, 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 EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE 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 CRACK/FRACTURE INVOLVING A MAKO IMPACTOR WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS PATIENT FACTORS DID NOT 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 EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT 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

    WHILE IMPACTING THE TIBIA BASEPLATE, THE BLUE PLASTIC PIECE ( PN 160177, LOT 12231214 ) BROKE IN 3 PIECES. ALSO, A NEW 3X9 POLY BROKE WHILE EXTRACTING.

    Description of Event or Problem · 1

    WHILE IMPACTING THE TIBIA BASEPLATE, THE BLUE PLASTIC PIECE ( PN 160177 LOT 12231214 ) BROKE IN 3 PIECES. ALSO, A NEW 3X9 POLY BROKE WHILE EXTRACTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9671 TIBIAL INLAY IMPACTOR HEAD PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 12231214

    Patients

    Seq Age Sex Outcome Treatment
    1 Other