BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 9 MM

    MDR report key: 11236856 · Received January 27, 2021

    Report

    Report Number
    3005985723-2021-00012
    Event Type
    Injury
    Date Received
    January 27, 2021
    Date of Event
    September 1, 2018
    Report Date
    January 27, 2021
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    UDI-DI
    00848486016500
    PMA / PMN Number
    K150307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: AN EVENT REGARDING PAIN INVOLVING A MAKO INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL, DIMENSIONAL, FUNCTIONAL AND MATERIAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. CLINICIAN REVIEW: THE AVAILABLE MEDICAL RECORDS WERE PROVIDED TO THE CONSULTING CLINICIAN FOR A REVIEW WHICH WAS REJECTED FOR MEDICAL REVIEW STATING," NO CLINICAL OR PMH, NO OPERATIVE REPORTS, NO IMAGING STUDIES TO REVIEW. BASED UPON THE INFORMATION SUBMITTED, NEITHER CONFIRMATION OF THE EVENT DESCRIPTIONS NOR PREPARATION OF A MEDICAL REPORT IS POSSIBLE FOR THIS CASE. BASED ON REVIEW OF THE ADDITIONAL RECORDS THE CLINICIAN NOTED THAT ," BASED UPON THE ADDITIONAL INFORMATION, INSUFFICIENT DATA STILL IS NOT AVAILABLE TO CONFIRM THE EVENT DESCRIPTIONS NOR PREPARE A MEDICAL REPORT FOR THIS CASE." DEVICE HISTORY REVIEW: 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 REPORTED LOT. CONCLUSION: IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE HAD PAIN. THE AVAILABLE MEDICAL RECORDS WERE PROVIDED TO THE CONSULTING CLINICIAN FOR A REVIEW WHICH WAS DEEMED INSUFFICIENT TO CONFIRM THE EVENT. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE BE DETERMINED BECAUSE INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS MEDICAL DOCUMENTATION AND RETURNED DEVICES ARE NEEDED. THE PATIENT WANTED TO KNOW IF THE DEVICE WAS PART OF RECALL, BASED ON THE REVIEW OF STRYKER DATABASE IT IS NOTED THAT THE DEVICE IS NOT PART OF ANY RECALL. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MCK FEMORAL-RM-LL-SZ 5; 180515 ;529564M. MCK TIBIAL BASEPLATE-RM/LL-SZ 4; 180614 ; 2662081701. SIMPLEX P - US FULL DOSE 10-PK; 61911010;RCZ041. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE PATIENT HAD BILATERAL TKA DONE ON (B)(6) 2018. PATIENT HAS BEEN EXPERIENCING PAIN ON BOTH KNEES SINCE HER SURGERY. PATIENT HAS HAD PHYSICAL THERAPY FOR ABOUT 6 WEEKS. THE PATIENT STATED HER PAIN HAS BEEN CONSISTENT AND HAS NEVER BEEN THE SAME SINCE HER SURGERY. PATIENT HAD LEFT KNEE X-RAY DONE ON (B)(6) 2020 AND AS PER HER SURGEON THE RESULTS SHOW HER LEFT KNEE IS NARROWING. SHE WOULD LIKE TO KNOW IF HER IMPLANTS ARE PART OF RECALL AND IS SEEKING COMPENSATION. THIS PI IS FOR THE RIGHT KNEE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132377 MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 9 MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 180734-2 Y9487W 00848486016500

    Patients

    Seq Age Sex Outcome Treatment
    1 Other