BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 6 - 8 MM

    MDR report key: 12252144 · Received July 30, 2021

    Report

    Report Number
    0002249697-2021-01295
    Event Type
    Injury
    Date Received
    July 30, 2021
    Date of Event
    July 6, 2021
    Report Date
    July 30, 2021
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    NPJ
    UDI-DI
    00848486016593
    PMA / PMN Number
    K150307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 TIBIAL BASEPLATE-LM/RL-SZ 6; CAT # 180606; LOT # 26311019-01. MCK FEMORAL-LM-RL-SZ 5; CAT # 180505; LOT # 590935-M. SIMPLEX HV US 1 PACK; CAT # 6194-1-001; LOT # 925AB939EA. 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 · 1

    DR...PERFORMED AN I&D WITH TIBIAL INSERT EXCHANGE DUE TO POSSIBLE INFECTION OF A LEFT MEDIAL UNI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151678 MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 6 - 8 MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ STRYKER ORTHOPAEDICS-MAHWAH 180736-1 2W2HPE 00848486016593

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R