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

Model Number	RKN130005
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient fell as he stepped backwards from mulch onto his driveway.The patient suffered a fracture to the femur which required screws.
Event or Problem Description
Patient fell as he stepped backwards from mulch onto his driveway.The patient suffered a fracture to the femur which required screws.Patient is recovering well.

• Brand Name: RHEO KNEE
• Common Device Name: PROSTHETIC KNEE
• Manufacturer (Section D): OSSUR HF.; grjothals 1-5; reykjavik, 110 ; IC 110
• MDR Report Key: 11777646
• Report Number: 3003764610-2021-00002
• Device Sequence Number: 14340168
• Product Code: ISW
• UDI-Device Identifier: 05690967598433
• UDI-Public: 05690967598433
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: RKN130005
• Device Catalogue Number: RKN130005
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/03/2021
• 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