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

Model Number RKNXC0003

Device Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problem Limb Fracture (4518)

Event Type  Injury  

Event Description

The user fell while using the prosthetic knee and fractured the elbow.

Event Description

The user fell while using the prosthetic knee and fractured the elbow.

Manufacturer Narrative

There is no indication of manufacturing or material failure in the device.The knee joint failed to provide the expected support, resulting in the user falling and fracturing his elbow.The user had cast placed on the elbow, with expectations for a complete recovery.The fall can be attributed to the user's failure to activate the correct mode or the user applied load on the knee when not fully extended.Following heel strike, the knee was unloaded and it transitioned into swing phase, rendering it incapable of providing support when the user reloaded the knee.

• 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: 18990291
• MDR Text Key: 338883831
• Report Number: 3003764610-2024-00002
• Device Sequence Number: 1
• Product Code: ISW
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other