MAUDE Adverse Event Report: OSSUR RHEO KNEE 3; ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXT

Model Number RKN130007

Device Problems Failure to Charge (1085); Device Operates Differently Than Expected (2913)

Patient Problem Fall (1848)

Event Date 03/01/2015

Event Type  malfunction  

Event Description

The above knee amputee patient experienced warning signals in the form of buzzing and flashing red light from the prosthetic knee and was not able to charge the knee.She knew it was not working but chose to walk on it anyway.One night she used her prosthesis to walk to the bathroom and fell while she was in the bathroom.She was not injured but she did need to call the fire department to help her back up because the space was too confined for her to get up on her own.

Manufacturer Narrative

The event is considered to be a result of the user operating the unit while being aware that it was not turned on.In case of this event the user can use a manual lock to lock the unit in stance.

• Brand Name: RHEO KNEE 3
• Type of Device: ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXT
• Manufacturer (Section D): OSSUR; reykjavik ; IC
• Manufacturer Contact: karen montes ; 27051 towne centre; foothill ranch, CA 92610 ; 9493823741
• MDR Report Key: 4743278
• MDR Text Key: 5703300
• Report Number: 3003764610-2015-00009
• Device Sequence Number: 1
• Product Code: ISW
• 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
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RKN130007
• Device Catalogue Number: RKN130007
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/31/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 113