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

Model Number RKN13110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Type  Injury  

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 Description

The patient fell and broke the femur head.

• Brand Name: RHEO KNEE 3
• Type of Device: 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: 8331131
• MDR Text Key: 135876368
• Report Number: 3003764610-2019-00004
• Device Sequence Number: 1
• Product Code: ISW
• UDI-Device Identifier: 05690967596644
• UDI-Public: 05690967596644
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RKN13110
• Device Catalogue Number: RKN13110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization