BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK TIBIAL ONLAY INSERT-SZ 8-8MM

    MDR report key: 6386271 · Received March 7, 2017

    Report

    Report Number
    3005985723-2017-00114
    Event Type
    Injury
    Date Received
    March 7, 2017
    Date of Event
    February 8, 2017
    Report Date
    March 7, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON WITH NO RELEVANT REPORTED DISCREPANCIES. LOT ID: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK TIBIAL BASEPLATE-RM/LL-SZ 8; CAT# 180618; LOT# 26550115-01. MCK FEMORAL-RM-LL-SZ 6; CAT# 180516; LOT# 444927-M. MCK PATELLOFEMORAL-R-SZ 6; CAT# 180416; LOT# 224545D-1. 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    CONVERSION OF MAKO BICOMPARTMENTAL TO PRIMARY KNEE. UPDATE PER SALES REP RECEIVED ON 01-MAR-2017: PATIENT COMPLAINED OF KNEE PAIN AFTER PRIMARY SURGERY. THIS WAS A REVISION OF A PRIMARY SURGERY. NO DEVICE RELATING FACTORS WERE APPARENT. SURGEON DID COMMENT THE PATIENT WAS LIKELY A NARCOTICS SEEKER. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165609 MCK TIBIAL ONLAY INSERT-SZ 8-8MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 12020415-1

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R