BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK TIBIAL ONLAY INSERT-SZ 4-8MM

    MDR report key: 20463774 · Received October 16, 2024

    Report

    Report Number
    3005985723-2024-00199
    Event Type
    Injury
    Date Received
    October 16, 2024
    Date of Event
    September 20, 2024
    Report Date
    November 7, 2024
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    UDI-DI
    00848486000882
    PMA / PMN Number
    K090763
    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: MCK FEMORAL-RM-LL-SZ 3; CAT# 180513; LOT# 26240615-01. MCK TIBIAL BASEPLATE-RM/LL-SZ 4; CAT# 180614; LOT# 26480815-01. MAKO UKR X3 ONLAY INSERT SIZE 3 - 8 MM; CAT# 180733-1-E; LOT# UNKNOWN. TRITANIUM PATELLA-ASYMMETRIC; CAT# 5552-L-299; LOT# WJX31. MCK TIBIAL BASEPLATE-LM/RL-SZ 3; CAT# 180603; LOT# 26031023-01. MCK FEMORAL-LM-RL-SZ 3; CAT# 180503; LOT# CPB4-1. MCK PATELLOFEMORAL-R-SZ 3; CAT# 180413; LOT# A6LM-1. SIMPLEX HV US 1 PACK; CAT# 6194-1-001; LOT# 333AB922IE. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    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 HAS BEEN NO OTHER SIMILAR EVENTS FOR THE STERILE LOT REFERENCED. 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

    I&D ON A RIGHT KNEE THAT HAD AN MCK UNI ON BOTH THE MEDIAL AND LATERAL SIDES. THIS WAS DUE TO SUSPECTED INFECTION.

    Description of Event or Problem · 0

    I&D ON A RIGHT KNEE THAT HAD AN MCK UNI ON BOTH THE MEDIAL AND LATERAL SIDES. THIS WAS DUE TO SUSPECTED INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2557179 MCK TIBIAL ONLAY INSERT-SZ 4-8MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 12120515-2 00848486000882

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention| H