BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK TIBIAL ONLAY INSERT-SZ 6-8MM

    MDR report key: 6772247 · Received August 7, 2017

    Report

    Report Number
    3005985723-2017-00359
    Event Type
    Injury
    Date Received
    August 7, 2017
    Date of Event
    July 11, 2017
    Report Date
    October 11, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    UDI-DI
    00848486000943
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A MAKO INSERT WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: COULD NOT BE PERFORMED AS THE SUBJECT DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: NO PATIENT MEDICAL RECORDS WERE AVAILABLE FOR REVIEW. DEVICE HISTORY REVIEW: THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT OR STERILE LOT REFERENCED. CONCLUSIONS: THE INFECTION WAS CLINICALLY CONFIRMED AS PER THE REPORTED EVENT BUT A ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOODWORK FOR INFECTION WERE NOT PROVIDED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND/OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK FEMORAL-LM-RL-SZ 6; CAT# 180506; LOT# 473712-M; MCK TIBIAL BASEPLATE-LM/RL-SZ 6; CAT# 180606; LOT# 26130816-01. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THERE HAVE BEEN NO OTHER EVENTS FOR THE STERILE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT HAD PAINFUL SWOLLEN KNEE. PATHOLOGY RESULTS CONCLUDED THAT THE KNEE WAS INFECTED. THE TIBIAL POLY INSERT WAS REMOVED, THE KNEE WAS THOROUGHLY IRRIGATED, AND A REPLACEMENT POLY LINER WAS INSERTED. TWO WEEKS AFTER PRIMARY PROCEDURE.

    Description of Event or Problem · 1

    PATIENT HAD PAINFUL SWOLLEN KNEE. PATHOLOGY RESULTS CONCLUDED THAT THE KNEE WAS INFECTED. THE TIBIAL POLY INSERT WAS REMOVED, THE KNEE WAS THOROUGHLY IRRIGATED, AND A REPLACEMENT POLY LINER WAS INSERTED. TWO WEEKS AFTER PRIMARY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551724 MCK TIBIAL ONLAY INSERT-SZ 6-8MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY NPJ MAKO SURGICAL CORP. 12080316-1 00848486000943

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R