BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO UKR X3 ONLAY INSERT SIZE 6 - 8 MM

    MDR report key: 17438997 · Received August 1, 2023

    Report

    Report Number
    3005985723-2023-00123
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    July 15, 2023
    Report Date
    August 1, 2023
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    UDI-DI
    07613327386127
    PMA / PMN Number
    K180612
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK FEMORAL-LM-RL-SZ 4; CAT# 180504; LOT# 5VGW-1; MCK TIBIAL BASEPLATE-LM/RL-SZ 6; CAT# 180606; LOT# 26721022-01. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED: PERFORMED AN I&D POLY SWAP OF A LEFT MEDIAL UNI DUE TO POSSIBLE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261680 MAKO UKR X3 ONLAY INSERT SIZE 6 - 8 MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. H91KD6 07613327386127

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Hospitalization| R