BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_MAKO PKA

    MDR report key: 14201223 · Received April 26, 2022

    Report

    Report Number
    3005985723-2022-00049
    Event Type
    Injury
    Date Received
    April 26, 2022
    Date of Event
    January 14, 2019
    Report Date
    November 21, 2022
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 AN UNKNOWN MAKO KNEE 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: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    DR. PERFORMED INITIAL MEDIAL UKA SURGERY ON THE PATIENT'S RIGHT KNEE AND FOLLOWED UP WITH PATIENT POST-OPERATIVELY. 10-YEAR FOLLOW-UP OF THE PATIENT OCCURRED ON (B)(6) 2022. INFORMATION COLLECTED ON PATIENT REPORTED: PATIENT REPORTED A REVISION TO THEIR MEDIAL UKA ON (B)(6) 2019. REASON FOR REVISION WAS PAIN, WALKING LIMITED; PATIENT WAS REVISED TO A TKA.

    Description of Event or Problem · 0

    DR. PERFORMED INITIAL MEDIAL UKA SURGERY ON THE PATIENT'S RIGHT KNEE AND FOLLOWED UP WITH PATIENT POST-OPERATIVELY. 10-YEAR FOLLOW-UP OF THE PATIENT OCCURRED ON (B)(6)2022. INFORMATION COLLECTED ON PATIENT REPORTED: PATIENT REPORTED A REVISION TO THEIR MEDIAL UKA ON 14JAN2019. REASON FOR REVISION WAS PAIN, WALKING LIMITED; PATIENT WAS REVISED TO A TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530675 UNKNOWN_MAKO PKA PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO NPJ MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R