BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL INLAY IMPACTOR HEAD

    MDR report key: 8038869 · Received November 5, 2018

    Report

    Report Number
    3005985723-2018-00651
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    October 8, 2018
    Report Date
    January 8, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING A MAKO IMPACTOR WAS REPORTED. THE EVENT WAS CONFIRMED THROUGH VISUAL INSPECTION OF THE PROVIDED PHOTOGRAPHS. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: THE REPORTED DEVICE WAS NOT RETURNED HOWEVER TWO PHOTOGRAPHS WERE PROVIDED FOR REVIEW. THE PHOTOGRAPHS PROVIDED SHOW THE BLUE PAD/FOOT SECTION OF THE MAKO IMPACTOR. NO PHOTOGRAPHS OF THE MAKO IMPACTOR BODY WERE PROVIDED. CATALOG NUMBER 160177 AND LOT CODE 19030314 ARE VISIBLE ON THE BLUE PAD/FOOT. DAMAGE IS VISIBLE ON THE BLUE FOOT/PAD. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: INDICATED ALL 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. CONCLUSION: IT WAS REPORTED THAT THE BLUE ¿PAD¿ ON THE TIBIAL IMPACTOR BROKE AND FELL OFF OF THE MAIN BODY OF THE IMPACTOR. THE REPORTED DEVICE WAS NOT RETURNED HOWEVER TWO PHOTOGRAPHS WERE PROVIDED FOR REVIEW. THE PHOTOGRAPHS PROVIDED SHOW THE BLUE PAD/FOOT SECTION OF THE MAKO IMPACTOR. NO PHOTOGRAPHS OF THE MAKO IMPACTOR BODY WERE PROVIDED. CATALOG NUMBER 160177 AND LOT CODE 19030314 ARE VISIBLE ON THE BLUE PAD/FOOT. DAMAGE IS VISIBLE ON THE RETURNED SECTION OF THE PRODUCT. THE EXACT CAUSE OF THE EVENT CANNOT BE CONFIRMED AS INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS FURTHER INFORMATION SUCH AS PRODUCT RETURN, IMAGES OF THE DEVICE TAKEN WHEN THE ALLEGED EVENT WAS IDENTIFIED AND OPERATIVE REPORT ARE REQUIRED TO COMPLETE THE INVESTIGATION FOR CONFIRMING THE EVENT AND DETERMINING A ROOT CAUSE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    USING IMPACTOR FOR TIBIAL BASEPLATE ON PKA AND THE BLUE ¿PAD¿ ON THE TIBIAL IMPACTOR BROKE AND FELL OFF OF THE MAIN BODY OF THE IMPACTOR.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    USING IMPACTOR FOR TIBIAL BASEPLATE ON PKA AND THE BLUE ¿PAD¿ ON THE TIBIAL IMPACTOR BROKE AND FELL OFF OF THE MAIN BODY OF THE IMPACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877134 TIBIAL INLAY IMPACTOR HEAD PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 19030314

    Patients

    Seq Age Sex Outcome Treatment
    1 Other