MAUDE Adverse Event Report: OSSUR RHEO KNEE; PROSTHETIC KNEE

Catalog Number	RKN130005
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	10/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device requires manufacturer evaluation to understand circumstances of the incident.Further information is needed to evaluate failure and root cause.
Event or Problem Description
According to the user the prosthetic knee unexpectedly gave way while the user was walking in their living room.As a result, the user fell and broke their femur.The user required medical attention and has been hospitalised.
Event or Problem Description
According to the user the prosthetic knee unexpectedly gave way while the user was walking in their living room.As a result, the user fell and broke their femur.The user required medical attention and has been hospitalised.
Additional Manufacturer Narrative
Root cause is likely due to a combination of factors, such as user and activity characteristics, though a contributory role of the device cannot be confirmed nor excluded.Device analysis showed no evidence of device failure causing the fall.Trans femoral amputees are known to be prone to falling irrespective of product failure.No further actions are considered warranted.

• Brand Name: RHEO KNEE
• Common Device Name: PROSTHETIC KNEE
• Manufacturer (Section D): OSSUR; grjothals 5; reykjavik, 110 ; IC 110
• Manufacturer Contact: katla axelsdottir ; grjothals 5; reykjavik, 110 ; IC 110
• MDR Report Key: 23356135
• Report Number: 3003764610-2025-00008
• Device Sequence Number: 8888293
• Product Code: ISY
• UDI-Device Identifier: 05690967598433
• UDI-Public: 05690967598433
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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 Catalogue Number: RKN130005
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown