BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK PATELLOFEMORAL-L-SZ 4

    MDR report key: 8329924 · Received February 11, 2019

    Report

    Report Number
    3005985723-2019-00128
    Event Type
    Injury
    Date Received
    February 11, 2019
    Date of Event
    January 15, 2019
    Report Date
    April 26, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    UDI-DI
    00848486000424
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING PATIENT FACTORS INVOLVING A MAKO PATELLOFEMORAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT WAS NOT RETURNED -MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -DEVICE HISTORY REVIEW: ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAS BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSION: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Description of Event or Problem · 0

    PATIENT UNDERWENT MAKO TKA REVISION FROM MAKO PF DUE TO PROGRESSIVE OA.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT UNDERWENT MAKO TKA REVISION FROM MAKO PF DUE TO PROGRESSIVE OA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122268 MCK PATELLOFEMORAL-L-SZ 4 PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY NPJ MAKO SURGICAL CORP. 237407-1 00848486000424

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R