MAUDE Adverse Event Report: COLLEGE PARK INDUSTRIES, INC. AURA KNEE; PROSTHETIC KNEE JOINT

Model Number	APKA 150
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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).
Event or Problem Description
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.

• Brand Name: AURA KNEE
• Common Device Name: PROSTHETIC KNEE JOINT
• Manufacturer (Section D): COLLEGE PARK INDUSTRIES, INC.; 27955 college park drive; warren MI 48088
• Manufacturer Contact: julie carver ; 27955 college park drive; warren, MI 48088 ; 5863542265
• MDR Report Key: 24619992
• Report Number: 1834241-2026-00001
• Device Sequence Number: 21290585
• Product Code: ISY
• UDI-Device Identifier: 00841747186707
• UDI-Public: 00841747186707
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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 Model Number: APKA 150
• Device Catalogue Number: APKA 150
• Device Lot Number: 08022024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female
• Patient Weight: 58 KG