BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK FEMORAL-LM-RL-SZ 6

    MDR report key: 6078915 · Received November 4, 2016

    Report

    Report Number
    3005985723-2016-00362
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    October 7, 2016
    Report Date
    January 17, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: MCK TIBIAL BASEPLATE-LM/RL-SZ 7; CAT# 180607; LOT# 26270315-01. MCK TIBIAL ONLAY INSERT-SZ 7-8MM; CAT# 180707-1; LOT# 120402013-1. MCK PATELLOFEMORAL-L-SZ 7; CAT# 180407; LOT# 2349521-1. MCK PATELLA RESURFACING ROUND DOME-38MM; CAT# 180320-5; LOT# 12350515-1. 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 NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AT THE LATER TIME IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION DUE TO PATIENT FACTORS (ADVANCED DISEASE OF ARTHRITIS) INVOLVING A MAKO FEMORAL COMPONENT 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: NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. -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 INFORMATION WAS PROVIDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Description of Event or Problem · 1

    REP REPORTED REVISION OF LEFT KNEE OF PATIENT FOR ADVANCED DISEASE OF ARTHRITIS.

    Description of Event or Problem · 1

    REP REPORTED REVISION OF LEFT KNEE OF PATIENT FOR ADVANCED DISEASE OF ARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729521 MCK FEMORAL-LM-RL-SZ 6 PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 2355921-1

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention