BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK TIBIAL ONLAY INSERT-SZ 6-8MM

    MDR report key: 5248519 · Received November 24, 2015

    Report

    Report Number
    3005985723-2015-00278
    Event Type
    Injury
    Date Received
    November 24, 2015
    Date of Event
    November 6, 2015
    Report Date
    November 6, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN INVOLVING A MAKO INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT INDICATED: THE MOST COMMON REASON FOR PERSISTENT PAIN REQUIRING REVISION OF A UNICONDYLAR TO A TOTAL KNEE ARTHROPLASTY IS PROGRESSION OF OSTEOARTHRITIS TO THE OTHER KNEE COMPARTMENTS. THERE IS NO EVIDENCE THAT FACTORS OF FAULTY COMPONENT DESIGN, MANUFACTURING OR MATERIALS WERE RESPONSIBLE FOR THIS CLINICAL SITUATION. DEVICE HISTORY REVIEW: INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW: NOT PERFORMED AS NO DEVICE SPECIFIC FAILURE MODES WERE IDENTIFIED. CONCLUSIONS: A REVIEW OF THE PROVIDED RECORDS BY A CLINICAL CONSULTANT INDICATED THERE IS NO EVIDENCE THAT FACTORS OF FAULTY COMPONENT DESIGN, MANUFACTURING OR MATERIALS WERE RESPONSIBLE FOR THIS CLINICAL SITUATION. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND/OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: MCK TIBIAL BASEPLATE-LM/RL-SZ 6; CAT# 180606; LOT# 26160214-01. MCK FEMORAL-LM-RL-SZ 5; CAT# 180505; LOT# 415610-M. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DR. (B)(6) PERFORMED A REVISION ON A PREVIOUS MEDIAL MAKO KNEE TO A TOTAL KNEE REPLACEMENT. PATIENT REVISED DUE TO PERSISTENT PAIN IN LEFT KNEE.

    Description of Event or Problem · 1

    DR. (B)(6) PERFORMED A REVISION ON A PREVIOUS MEDIAL MAKO KNEE TO A TOTAL KNEE REPLACEMENT. PATIENT REVISED DUE TO PERSISTENT PAIN IN LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776019 MCK TIBIAL ONLAY INSERT-SZ 6-8MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 12060414-1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention