BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO UKR X3 ONLAY INSERT SIZE 5 - 8 MM

    MDR report key: 13221431 · Received January 11, 2022

    Report

    Report Number
    0002249697-2022-00054
    Event Type
    Injury
    Date Received
    January 11, 2022
    Date of Event
    December 15, 2021
    Report Date
    January 11, 2022
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    NPJ
    UDI-DI
    07613327386028
    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

    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. 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. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK FEMORAL-RM-LL-SZ 4; CAT#:180514 ; LOT#: 3HB5-1. MCK TIBIAL BASEPLATE-RM/LL-SZ 5; CAT#:180615 ; LOT#: 0000951218. SIMPLEX HV US 1 PACK; CAT#: 6194-1-001 ; LOT#: 110AA903JB. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Description of Event or Problem · 0

    DR. PERFORMED AN I&D AND REVISED A MAKO TIBIAL INSERT THAT WAS ORIGINALLY DONE BY DR. ON (B)(6) 2021 DUE TO INFECTION. RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2624219 MAKO UKR X3 ONLAY INSERT SIZE 5 - 8 MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ STRYKER ORTHOPAEDICS-MAHWAH 180735-1-E TT3DLV 07613327386028

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Hospitalization| R