BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK TIBIAL ONLAY INSERT-SZ 2-8MM

    MDR report key: 5732381 · Received June 17, 2016

    Report

    Report Number
    3005985723-2016-00187
    Event Type
    Injury
    Date Received
    June 17, 2016
    Date of Event
    May 20, 2016
    Report Date
    May 20, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: MCK FEMORAL-RM-LL-SZ 2; CAT# 180512; LOT# 402144-M MCK TIBIAL BASEPLATE-RM/LL-SZ 2; CAT# 180612; LOT# 26020314-01. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL 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.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: AN EVENT REGARDING REVISION INVOLVING AN MAKO INSERT 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: THE PROVIDED MEDICAL INFORMATION WAS SUBMITTED TO A CONSULTING CLINICIAN WHO DEEMED IT INSUFFICIENT FOR A MEDICAL REVIEW. DEVICE HISTORY REVIEW: 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 MEDICAL INFORMATION WAS PROVIDED. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    DR. (B)(6) REVISED A MEDIAL MAKO PKA ORIGINALLY DONE (B)(6) 2014 BY DR. (B)(6).. HE REVISED DUE TO PROGRESSION OF DISEASE TO THE PF JOINT.

    Description of Event or Problem · 1

    DR. (B)(6) REVISED A MEDIAL MAKO PKA ORIGINALLY DONE (B)(6) 2014 BY DR. (B)(6). HE REVISED DUE TO PROGRESSION OF DISEASE TO THE PF JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387864 MCK TIBIAL ONLAY INSERT-SZ 2-8MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 12090114-1

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention