MAUDE Adverse Event Report: OSSUR HF RHEO KNEE 3; PROSTHETIC KNEE

Model Number	RKN13110
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient fell and the femur head broke.Patient has weakened bones due to cancer.The injury has healed completely and the patient is doing fine.The device has been analyzed and no product malfunction was identified.
Event or Problem Description
The patient fell and broke the femur head.

• Brand Name: RHEO KNEE 3
• Common Device Name: PROSTHETIC KNEE
• Manufacturer (Section D): OSSUR HF; grjothals 1-5; reykjavik, 110 ; IC 110
• MDR Report Key: 8331131
• Report Number: 3003764610-2019-00004
• Device Sequence Number: 13468294
• Product Code: ISW
• UDI-Device Identifier: 05690967596644
• UDI-Public: 05690967596644
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 02/12/2019

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: RKN13110
• Device Catalogue Number: RKN13110
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 02/12/2019
• 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