BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 22635886 · Received July 28, 2025

    Report

    Report Number
    0002249697-2025-00731
    Event Type
    Injury
    Date Received
    July 28, 2025
    Date of Event
    July 1, 2025
    Report Date
    July 28, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING ROM INVOLVING AN UNKNOWN TRIATHLON INSERT 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 REMAINS IMPLANTED. 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. CONCLUSION: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS PATHOLOGY REPORTS, PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY/REVISION 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 ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA STRYKER FACEBOOK PAGE, "I HAD MAKO ALMOST 10 MONTHS AGO AND MY KNEE IS STILL STIFF." ADDITIONAL FACEBOOK COMMENT RECEIVED, "BUT NOW, EVERY TIME I STAND UP, I HAVE PAIN ON OPPOSITE SIDE OF MY KNEE. ALSO, WHEN I STAND, MY KNEE IS NUMB AND FOR SEVERAL SECONDS I HAVE TO STAND IN ONE POSITION UNTIL THE NUMBNESS STARTS TO FADE. THEN WHEN I DO WALK, I FEEL PRESSURE AROUND MY KNEE IN EVERY STEP. LAST APPOINTMENT WITH NURSE PRACTITIONER I WAS TOLD IT WAS 'PART OF THE HEALING PROCESS.'"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610061 UNKNOWN KNEE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other