BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO UKR X3 ONLAY INSERT SIZE 5 - 8 MM

    MDR report key: 11694932 · Received April 20, 2021

    Report

    Report Number
    3005985723-2021-00072
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 20, 2021
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    UDI-DI
    07613327386028
    PMA / PMN Number
    K150307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 REFERENCED. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE STERILE LOT REFERENCED. CONCLUSIONS: 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. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: 180514;MCK FEMORAL-RM-LL-SZ 4;2738-1. 180615;MCK TIBIAL BASEPLATE-RM/LL-SZ 5;126140220-01. 6194-1-001;SIMPLEX HV US 1 PACK;1013AB843CB. 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 POLY EXCHANGE ON A RIGHT MAKO MEDIAL UNI ORIGINALLY DONE (B)(6) 2021 DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593455 MAKO UKR X3 ONLAY INSERT SIZE 5 - 8 MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 180735-1-E EN747D 07613327386028

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R