BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 6 - 9 MM

    MDR report key: 17359430 · Received July 20, 2023

    Report

    Report Number
    3005985723-2023-00118
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    June 26, 2023
    Report Date
    August 11, 2023
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    UDI-DI
    00848486016609
    PMA / PMN Number
    K150307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK FEMORAL-RM-LL-SZ 5; 180515 ; (B)(6). MCK TIBIAL BASEPLATE-RM/LL-SZ 6; 180616; (B)(6). IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT AN EVENT REGARDING PAIN INVOLVING A MAKO INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF THE DEVICE, PATHOLOGY REPORTS, PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    REVISED A RIGHT MEDIAL UNI DUE TO PAIN. THE PATIENT HAD TAKEN A FALL RECENTLY. HE REVISED TO A PRIMARY TRIATHLON.

    Description of Event or Problem · 0

    REVISED A RIGHT MEDIAL UNI DUE TO PAIN. THE PATIENT HAD TAKEN A FALL RECENTLY. HE REVISED TO A PRIMARY TRIATHLON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754670 MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 6 - 9 MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 180736-2 7A5V5E 00848486016609

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention| H