BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK PATELLOFEMORAL-L-SZ 7

    MDR report key: 23167997 · Received September 29, 2025

    Report

    Report Number
    3005985723-2025-00451
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    September 3, 2025
    Report Date
    February 5, 2026
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486000455
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK PATELLA RESURFACING ROUND DOME-41MM; CAT# 180320-6; LOT# 12100621. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING PAIN INVOLVING A MAKO FEMORAL COMPONENT 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. DEVICE HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE THE REPORTED DEVICE WAS MANUFACTURED WITH NO REPORTED RELEVANT DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSION: IT WAS REPORTED THAT, A PHYSICIAN INFORMED SALES REP THAT A PF JOINT REPLACEMENT PATIENT WAS SCHEDULED FOR REVISION NEXT MONTH DUE TO CONTINUED PAIN. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION INCLUDING OPERATIVE REPORTS, PROGRESS NOTES, X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A PHYSICIAN INFORMED SALEREP THAT A PF JOINT REPLACEMENT PATIENT WAS SCHEDULED FOR REVISION NEXT MONTH DUE TO CONTINUED PAIN.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408906 MCK PATELLOFEMORAL-L-SZ 7 ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 633747-M 00848486000455

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other