MAUDE Adverse Event Report: OSSUR RHEO KNEE XC; PROSTHETIC KNEE

Catalog Number	RKNXC0003
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	06/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
User fell and broke a finger when breaking the fall.
Additional Manufacturer Narrative
Root cause of event is most likely on/off button out of specified tolerance.Risk to user is considered negligible based on pms data.Issue is being addressed through nc.No further actions are considered warranted at this time.
Event or Problem Description
User fell and broke a finger when breaking the fall.

• Brand Name: RHEO KNEE XC
• Common Device Name: PROSTHETIC KNEE
• Manufacturer (Section D): OSSUR; grjothals 1-5; reykjavik, 110 ; IC 110
• Manufacturer Contact: katla axelsdottir ; grjothals 1-5; reykjavik, 110 ; IC 110
• MDR Report Key: 22747264
• Report Number: 3003764610-2025-00006
• Device Sequence Number: 4526662
• Product Code: ISY
• UDI-Device Identifier: 05690977467804
• UDI-Public: 05690977467804
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: RKNXC0003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 08/25/2025
• 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: Other
• Patient Sex: Unknown