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

Model Number	RKNX230
Medical Device Problem Codes	Inadequate User Interface (2958); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	06/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was getting out of bed with the prosthetic knee and fell.As a result of the fall he had a femoral neck fracture.
Event or Problem Description
The patient was getting out of bed with the prosthetic knee and fell.As a result of the fall he had a femoral neck fracture.

• Brand Name: RHEO KNEE
• Common Device Name: PROSTHETIC KNEE
• Manufacturer (Section D): OSSUR HF; grjothals 1-5; reykjavik, 110 ; IC 110
• Manufacturer Contact: katla axelsdottir ; grjothals 1-5; reykjavik, 110 ; IC 110
• MDR Report Key: 17297020
• Report Number: 3003764610-2023-00015
• Device Sequence Number: 7145949
• Product Code: ISW
• UDI-Device Identifier: 05690977467873
• UDI-Public: 05690977467873
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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: RKNX230
• Device Catalogue Number: RKNXC230
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/24/2023
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown