BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLEG PARK

    MDR report key: 19279293 · Received May 9, 2024

    Report

    Report Number
    1834241-2024-00001
    Event Type
    Injury
    Date Received
    May 9, 2024
    Date of Event
    February 19, 2024
    Report Date
    April 19, 2024
    Manufacturer
    COLLEGE PARK INDUSTRIES, INC
    Product Code
    ISH
    UDI-DI
    00195411041428
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) OF AMPUTEE ASSOCIATES/VSA PROSTHETIC CENTER IN MARIETTA, GA EXPLAINED THE USER HAD FALLEN A FEW MONTHS PRIOR WHILE THE FOOT WAS STILL UNDER WARRANTY, CAUSING HIM TO LOSE THEIR BALANCE AND "THROWING HIM SIDEWAYS." (B)(6) STATED THE HYDRAULICS FELT LIKE IT HAD AIR BUBBLES AND WAS CYCLING SLOW, THEN FAST AND DID NOT FEEL SMOOTH. THE PATIENT IS AN ABOVE KNEE AMPUTEE AND WEARS NOT ONLY THE COLLEGE PARK ODYSSEY K3 FOOT, BUT ALSO A COMPETITORS MICROPROCESSOR KNEE. ERIC SAID IT WAS STUCK IN A DORSIFLEX POSITION AND IT COULD HAVE EXASPERATED THE KNEE WHEN THE PATIENT WASN'T EXPECTING IT. THE INVESTIGATION OF THE RETURNED ODYSSEY K3 FOOT CONFIRMED THE ANKLE AND ADJUSTMENT VALVES WERE FUNCTIONING AS INTENDED. INVESTIGATION ALSO FOUND AIR IN THE SYSTEM FROM TWO WORN SEALS. THE AIR IN THE SYSTEM DID NOT PREVENT PROPER FUNCTIONING OF THE ANKLE, AS THE ANKLE WAS FOUND TO ADJUST SMOOTHLY. FOOT WAS ALSO FOUND TO HAVE DRY AREAS ON THE AXIAL PIN, BUT AXIAL PIN WAS FREE OF STRIATIONS AND DAMAGE INDICATING PIN CONTINUED TO ROTATE AS INDENTED. THE SEALS DO WEAR DUE TO NORMAL USE. THE OIL LEAK FOUND DURING THE INVESTIGATION WOULD NOT CAUSE THE FOOT TO MALFUNCTION, AS CLAIMED, BUT COULD CAUSE A SLIGHT DIFFERENCE IN PRESSURE, WHICH WOULD BE UNNOTICEABLE TO THE PATIENT. ADDITIONALLY, COLLEGE PARK IFU'S STATES COMPATIBILITY AND COMPLIANCE ARE ACHIEVED ONLY WHEN COLLEGE PARK PRODUCTS ARE USED WITH OTHER RECOMMENDED COLLEGE PARK PRODUCTS. THE COLLEGE PARK ODYSSEY K3 FOOT WAS BEING USED WITH A COMPETITORS MICROPROCESSOR KNEE. SINCE THE FOOT FUNCTIONED SMOOTHLY AND AS INTENDED, IT IS UNLIKELY IT EXASPERATED THE MICROPROCESSOR KNEE. INVESTIGATION FINDINGS: CPI HAS REVIEWED THE REPORTED PROBLEM, AND WE CONCLUDE THAT NO FURTHER INVESTIGATION IS NECESSARY BECAUSE THE FOOT FUNCTIONED AS INTENDED. THE FOOT APPEARED TO BE UNDER NORMAL WEAR & TEAR. COLLEGE PARK WILL CONTINUE TO MONITOR THE RETURNS FOR TRENDS.

    Description of Event or Problem · 0

    PATIENT FELL A FEW MONTHS AGO AND WAS HOSPITALIZED FOR A BROKEN HIP AND WAS NOT ABLE TO COME IN TO SEE HIS PROSTHETIST DUE TO HIS INJURY. THE PATIENT IS AN ABOVE KNEE AMPUTEE AND ALSO WEARS A PROSTHETIC MICROPROCESSOR KNEE (THIS PRODUCT IS NOT MANUFACTURED BY COLLEGE PARK). THE PROSTHETIST COULD NOT CONFIRM IF THE ODYSSEY K3 PROSTHETIC FOOT OR PROSTHETIC MICROPROCESSOR KNEE CONTRIBUTED TO THE FALL. THE PROSTHETIST DID MENTION THAT THE ODYSSEY K3 PROSTHETIC FOOT DID NOT FEEL SMOOTH IN MOTION. COLLEGE PARK WANTED TO REPORT THE INCIDENT SINCE THE FALL CAUSED THE PATIENT TO HAVE SURGERY. THE ODYSSEY K3 FOOT HAS A 3 YEAR WARRANTY AND THIS PRODUCT IS ONE MONTH FROM BEING OUT OF WARRANTY.

    Description of Event or Problem · 0

    PATIENT FELL A FEW MONTHS AGO AND WAS HOSPITALIZED FOR A BROKEN HIP AND WAS NOT ABLE TO COME IN TO SEE HIS PROSTHETIST DUE TO HIS INJURY. THE PATIENT IS AN ABOVE KNEE AMPUTEE AND ALSO WEARS A PROSTHETIC MICROPROCESSOR KNEE (THIS PRODUCT IS NOT MANUFACTURED BY COLLEGE PARK). THE PROSTHETIST COULD NOT CONFIRM IF THE ODYSSEY K3 PROSTHETIC FOOT OR PROSTHETIC MICROPROCESSOR KNEE CONTRIBUTED TO THE FALL. THE PROSTHETIST DID MENTION THAT THE ODYSSEY K3 PROSTHETIC FOOT DID NOT FEEL SMOOTH IN MOTION. COLLEGE PARK WANTED TO REPORT THE INCIDENT SINCE THE FALL CAUSED THE PATIENT TO HAVE SURGERY. THE ODYSSEY K3 FOOT HAS A 3 YEAR WARRANTY AND THIS PRODUCT IS ONE MONTH FROM BEING OUT OF WARRANTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490417 COLLEG PARK ODYSSEY K3 ISH COLLEGE PARK INDUSTRIES, INC ODK3 EN 26 D2 01292021 00195411041428

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Hospitalization ODYSSEY K3 - PROSTHETIST FITTED ON (B)(6) 2021.