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

Model Number RKNXC0003

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

The patient was walking in the kitchen, took a hard fall and broke her ankle.She believes the knee felt as though it locked up but was not sure because it happened so fast.

Event Description

The patient was walking in the kitchen, took a hard fall and broke her ankle.

Manufacturer Narrative

When the patient was walking in the kitchen she took a hard fall and broke her ankle.The patient did not report any other issues leading up to the fall and had been comfortably wearing the knee daily for approx 3 months.

• Brand Name: RHEO KNEE XC
• 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: 13480477
• MDR Text Key: 289351227
• Report Number: 3003764610-2022-00001
• Device Sequence Number: 1
• Product Code: ISW
• UDI-Device Identifier: 05690977467804
• UDI-Public: 05690977467804
• 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
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: RKNXC0003
• Device Catalogue Number: RKNXC0003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other