MAUDE Adverse Event Report: RHEO KNEE XC; PROSTHETIC KNEE

Model Number RKNXC0002

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

The user stepped down from a terrace to a meadow and fell, leading to broken femur.

Manufacturer Narrative

User fell when stepping down from a terrace on uneven ground and fractured her femur bone necessitating surgical intervention.The fall is considered likely to be related to knee being unable to detect heel strike due to complexity of user's action in a complex environment, however unable to fully confirm root cause.Device was found fully functional and passed all quality checks and user testing.Likelihood of failure leading to hazardous event and resulting in a serious injury is considered to be remote.Issue will continue to be monitored.

Event Description

The user stepped down from a terrace to a meadow and fell, leading to broken femur.

• Brand Name: RHEO KNEE XC
• Type of Device: PROSTHETIC KNEE
• MDR Report Key: 12604533
• MDR Text Key: 275880960
• Report Number: 3003764610-2021-00003
• Device Sequence Number: 1
• Product Code: ISW
• UDI-Device Identifier: 05690977467798
• UDI-Public: 05690977467798
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RKNXC0002
• Device Catalogue Number: RKNXC0002
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/14/2021
• 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): Other