BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRYKER MCK 6X10 INSERT

    MDR report key: 24979516 · Received April 24, 2026

    Report

    Report Number
    3005985723-2026-00192
    Event Type
    Injury
    Date Received
    April 24, 2026
    Date of Event
    March 30, 2026
    Report Date
    April 24, 2026
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: CAT#;DEVICE NAME; LOT#: UNK_OFL; UNKNOWN STRYKER MCK 6LM FEMUR; UNKNOWN. UNK_OFL; UNKNOWN STRYKER MCK 6LM TIBIAL BASEPLATE; UNKNOWN. 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

    THE FOLLOWING INFORMATION WAS PROVIDED: REVISED A LEFT MAKO MEDIAL UNI DUE TO INFECTION. HE REVISED TO A PRIMARY TRIATHLON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038020 UNKNOWN STRYKER MCK 6X10 INSERT PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| R