BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO UKR X3 ONLAY INSERT SIZE 4 - 8 MM

    MDR report key: 14878732 · Received June 30, 2022

    Report

    Report Number
    3005985723-2022-00087
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    June 15, 2022
    Report Date
    June 30, 2022
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    UDI-DI
    07613327385984
    PMA / PMN Number
    K150307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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-RM-LL-SZ 5; CAT#180515 ; LOT# 4GM1-1. MCK TIBIAL BASEPLATE-RM/LL-SZ 4; CAT# 180614; LOT# 26050321-01. 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

    IT WAS REPORTED THAT THE PATIENT'S RIGHT MEDIAL PKA WAS REVISED. AS REPORTED: "REVISION W/ POLY EXCHANGE. INFECTION." REP PROVIDED PRIMARY AND REVISION USAGE AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366230 MAKO UKR X3 ONLAY INSERT SIZE 4 - 8 MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 180734-1-E AX5A49 07613327385984

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Hospitalization| R