BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RESTORIS LATERAL INSERT - PKA 3.0 2.8MM

    MDR report key: 16574234 · Received March 20, 2023

    Report

    Report Number
    3005985723-2023-00058
    Event Type
    Injury
    Date Received
    March 20, 2023
    Date of Event
    February 23, 2023
    Report Date
    March 20, 2023
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: SIZE 1 LM/RL FEMUR LOT - UNKNOWN. SIZE 2 LM/RL TIBIAL BASEPLATE LOT -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

    DR. INFORMED THAT HE PERFORMED A MAKO LATERAL PARTIAL KNEE REPLACEMENT ON PATIENT ABOUT 3.5 YEARS AGO. THE PATIENT WAS COMPLAINING OF PAIN AND HE PERFORMED A SCOPE YESTERDAY ON (B)(6) 2023 AND NOTICED THE TIBIAL POLY IS "STAINED BROWN, IT'S PITTING AND WHEN YOU LOOK AT IT FROM THE FRONT YOU CAN SEE IT'S NOT FLAT AND SHOWS SOME CONCAVITY WHERE THE BROWN SPOT IS". HE ALSO INFORMED HE FOUND A CHONDRAL LESION ON THE PATIENT'S MFC. HE STATED THAT THIS IMPLANT HAS ONLY BEEN IN FOR 3 1/2 YEARS AND THIS REALLY SHOULDN'T' HAPPEN. THE SCOPE HE PERFORMED YESTERDAY WAS DUE TO THE PATIENT'S CONTINUED PAIN. CASE TYPE / APPLICATION: PKA (MICS) "RIGHT LATERAL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1650307 UNKNOWN RESTORIS LATERAL INSERT - PKA 3.0 2.8MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H