BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO UKR X3 ONLAY INSERT SIZE 7 - 8 MM

    MDR report key: 21940833 · Received May 1, 2025

    Report

    Report Number
    3005985723-2025-00194
    Event Type
    Injury
    Date Received
    May 1, 2025
    Date of Event
    April 7, 2025
    Report Date
    May 1, 2025
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    UDI-DI
    07613327386226
    PMA / PMN Number
    K180612
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK FEMORAL-RM-LL-SZ 7; CAT#: 180517; LOT#: C4BB-1. MCK TIBIAL BASEPLATE-RM/LL-SZ 7; CAT#: 180617; LOT#: 26021223-01. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. REPORTED EVENT: AN EVENT REGARDING INFECTION INVOLVING A MAKO INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT OR STERILE LOT REFENCED. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. ALL STRYKER PRODUCTS SOLD AS STERILE ARE VALIDATED TO A MINIMUM STERILITY ASSURANCE LEVEL SAL OF 10^-6 IN ACCORDANCE TO APPLICABLE ISO STANDARDS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF THE DEVICE, PATHOLOGY REPORTS, PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    AS REPORTED: "PATIENT IS S/P REV RTKA COMPLETED TODAY D/T INFECTION. NO ADDITIONAL INFORMATION PROVIDED." A RESTORIS MCK PARTIAL KNEE WAS CONVERTED TO A TRIATHLON PRO PS KNEE, AND THE PATIENT'S NATIVE PATELLA WAS RESURFACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194993 MAKO UKR X3 ONLAY INSERT SIZE 7 - 8 MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. NX79VW 07613327386226

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention| H