BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AURA KNEE

    MDR report key: 24619992 · Received March 17, 2026

    Report

    Report Number
    1834241-2026-00001
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 17, 2026
    Manufacturer
    COLLEGE PARK INDUSTRIES, INC.
    Product Code
    ISY
    UDI-DI
    00841747186707
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COLLEGE PARK INDUSTRIES, INC. IS CURRENTLY AWAITING THE RETURN OF THE PRODUCT TO CONDUCT A THOROUGH INVESTIGATION TO DETERMINE WHETHER THE PRODUCT FUNCTIONED AS INTENDED. THE PRODUCT IS CURRENTLY EN ROUTE TO US FROM GERMANY.

    Additional Manufacturer Narrative · 0

    COLLEGE PARK INDUSTRIES, INC. IS CURRENTLY AWAITING THE RETURN OF THE PRODUCT TO CONDUCT A THOROUGH INVESTIGATION TO DETERMINE WHETHER THE PRODUCT FUNCTIONED AS INTENDED. THE PRODUCT IS CURRENTLY EN ROUTE TO US FROM GERMANY. INVESTIGATION: COSMETIC APPEARANCE: THE KNEE WAS RETURNED WITH NORMAL WEAR OBSERVED ON THE ANKLE DOME. THE KNEE WAS ALSO RETURNED IN LOCK MODE. FUNCTIONAL TESTING: WHEN REVIEWED BY HAND WITHOUT ATTACHMENT TO A TESTING FOOT OR T-HANDLE THE KNEE WAS CONFIRMED TO BE IN LOCK MODE. DEPRESSING THE TEAL BUTTON INWARD RELEASED THE MANUAL LOCK, AND THE KNEE DISENGAGED FROM LOCK MODE AS EXPECTED. THE KNEE WAS THEN RETURNED TO LOCK MODE BY PRESSING THE TEAL BUTTON, AT WHICH POINT THE LOCK PROPERLY ENGAGED. CONCLUSION: THE RETURNED AURA POLYCENTRIC KNEE WAS EVALUATED AND FOUND TO FUNCTION PROPERLY AND AS INTENDED. THE LOCK MECHANISM ENGAGED AND DISENGAGED CORRECTLY, AND THE KNEE OPERATED WITHOUT ANY NOISE. THROUGH MULTIPLE TEST METHODS, THE KNEE CONSISTENTLY ENGAGED AND DISENGAGED THE LOCK. BASED ON THESE FINDINGS, ONE OF THE FOLLOWING SCENARIOS IS SUGGESTED: THE KNEE WAS BELIEVED TO BE PLACED IN LOCK MODE BUT WAS NOT PHYSICALLY ENGAGED, OR THE KNEE WAS ALREADY IN LOCK MODE AND WAS SUBSEQUENTLY SWITCHED TO UNLOCK MODE. COLLEGE PARK'S USER GUIDE PROVIDES INSTRUCTIONS FOR THE PROPER USE OF THE MANUAL LOCK FEATURE. INVESTIGATION FINDINGS: FOLLOWING THE INVESTIGATION, I CONCLUDE NO FURTHER ACTION IS NEEDED AT THIS TIME, AS THE REPORTED ISSUE HAS BEEN ATTRIBUTED TO NO TROUBLE FOUND AS KNEE FUNCTIONED PROPERLY. THE RETURNS DEPARTMENT WILL CONTINUE MONITORING DATA FOR ANY EMERGING TRENDS. (B)(4).

    Description of Event or Problem · 0

    THE USER PUT ON THE SHOWER LEG IN A SEATED POSITION, AS SHE DOES EVERY MORNING, AND SET THE KNEE JOINT TO "LOCK" SO THAT WHEN SHE STANDS UP, THE LEG IS FIXED AND DOES NOT BEND AGAIN. HOWEVER, THE LOCKING MECHANISM DID NOT ENGAGE. AS A RESULT, THE LEG BENT/COLLAPSED DESPITE BEING SET TO "LOCK," AND THE CUSTOMER FELL. SHE SPENT FIVE DAYS IN THE HOSPITAL. THE INJURIES INVOLVED THE RIBS AND LUMBAR VERTEBRAE. DUE TO THE PATIENT'S HEALTH CONDITION, SURGERY WAS NOT PERFORMED. INSTEAD, SHE RECEIVED CONSERVATIVE TREATMENT AND PAIN THERAPY.

    Description of Event or Problem · 0

    THE USER PUT ON THE SHOWER LEG IN A SEATED POSITION, AS SHE DOES EVERY MORNING, AND SET THE KNEE JOINT TO "LOCK" SO THAT WHEN SHE STANDS UP, THE LEG IS FIXED AND DOES NOT BEND AGAIN. HOWEVER, THE LOCKING MECHANISM DID NOT ENGAGE. AS A RESULT, THE LEG BENT/COLLAPSED DESPITE BEING SET TO "LOCK," AND THE CUSTOMER FELL. SHE SPENT FIVE DAYS IN THE HOSPITAL. THE INJURIES INVOLVED THE RIBS AND LUMBAR VERTEBRAE. DUE TO THE PATIENT'S HEALTH CONDITION, SURGERY WAS NOT PERFORMED. INSTEAD, SHE RECEIVED CONSERVATIVE TREATMENT AND PAIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433469 AURA KNEE PROSTHETIC KNEE JOINT ISY COLLEGE PARK INDUSTRIES, INC. APKA 150 08022024 00841747186707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization