BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK PATELLOFEMORAL-L-SZ 6

    MDR report key: 12951491 · Received December 7, 2021

    Report

    Report Number
    3005985723-2021-00205
    Event Type
    Injury
    Date Received
    December 7, 2021
    Date of Event
    November 12, 2021
    Report Date
    February 28, 2022
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    UDI-DI
    00848486000448
    PMA / PMN Number
    K082172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING PAIN INVOLVING A MAKO FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL, AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. COMPLAINT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF THE DEVICE, PATHOLOGY REPORTS, PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    DR. REVISED A LEFT MAKO UNI PATELLOFEMORAL TO A PRIMARY TOTAL KNEE DUE TO PAIN. ORIGINAL SURGERY WAS (B)(6) 2013. IT WAS A SIZE 6 MAKO MCK PATELLOFEMORAL AND THE ORIGINAL PATELLA USED WAS A COMPETITOR.

    Description of Event or Problem · 0

    DR. REVISED A LEFT MAKO UNI PATELLOFEMORAL TO A PRIMARY TOTAL KNEE DUE TO PAIN. ORIGINAL SURGERY WAS (B)(6) 2013. IT WAS A SIZE 6 MAKO MCK PATELLOFEMORAL AND THE ORIGINAL PATELLA USED WAS A COMPETITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850441 MCK PATELLOFEMORAL-L-SZ 6 PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 180406 UNKNOWN 00848486000448

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention| H