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

Model Number	RKNXC230
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Burn(s) (1757); Limb Fracture (4518)
Date of Event	10/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The knee was manufactured in april 2016 and had been in the field for over 7 years when the injury occurred.The user reported that the device did not provide flexion resistance from 0-5°.The likely reason for the user experiencing the resistance issue is the age of the actuator, which was installed on 2021-01-04 and was therefore almost 3 years old.It is likely that there was play in the unit which resulted in the user not feeling any resistance in the first few degrees of flexion.The problem is related to wear and tear during use and there is no evidence of other problems or manufacturing defects.
Event or Problem Description
The user was walking through the kitchen when the knee buckled, in an attempt to steady himself, the user grabbed the handle of a hot saucepan on a stove, spilling boiling water on his right arm and sustaining a scald.He landed on his left hand, fracturing his wrist.

• Brand Name: RHEO KNEE XC
• Common Device Name: PROSTHETIC KNEE
• Manufacturer (Section D): OSSUR HF; grjothals 1-5; reykjavik, 110 ; IC 110
• Manufacturer Contact: katla axelsdottir ; reykjavik, 110 ; IC 110
• MDR Report Key: 19762084
• Report Number: 3003764610-2024-00005
• Device Sequence Number: 8920250
• Product Code: ISW
• UDI-Device Identifier: 05690977467873
• UDI-Public: 05690977467873
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 07/17/2024

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 Model Number: RKNXC230
• Device Catalogue Number: RKNXC230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 07/17/2024
• 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