MAUDE Adverse Event Report: COLLEGE PARK INDUSTRIES, INC COLLEG PARK; ODYSSEY K3

Model Number	ODK3 EN 26 D2
Medical Device Problem Codes	Mechanical Problem (1384); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hip Fracture (2349)
Date of Event	02/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
(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.
Event or Problem Description
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.

• Brand Name: COLLEG PARK
• Common Device Name: ODYSSEY K3
• Manufacturer (Section D): COLLEGE PARK INDUSTRIES, INC; 27955 college park drive; warren MI 48088
• Manufacturer (Section G): COLLEGE PARK INDUSTRIES, INC; 27955 college park drive; warren 48088
• Manufacturer Contact: julie carver ; 27955 college park drive; warren, MI 48088 ; 5863542265
• MDR Report Key: 19279293
• Report Number: 1834241-2024-00001
• Device Sequence Number: 6320820
• Product Code: ISH
• UDI-Device Identifier: 00195411041428
• UDI-Public: 00195411041428
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Exemption Number: 510K
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/15/2024
• Device Model Number: ODK3 EN 26 D2
• Device Catalogue Number: ODK3 EN 26 D2
• Device Lot Number: 01292021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ODYSSEY K3 - PROSTHETIST FITTED ON (B)(6) 2021.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White