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

Model Number RKNX230

Device Problems Inadequate User Interface (2958); Insufficient Information (3190)

Patient Problem Hip Fracture (2349)

Event Date 06/25/2023

Event Type  Injury  

Event Description

The patient was getting out of bed with the prosthetic knee and fell.As a result of the fall he had a femoral neck fracture.

Event Description

The patient was getting out of bed with the prosthetic knee and fell.As a result of the fall he had a femoral neck fracture.

• Brand Name: RHEO KNEE
• 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: 17297020
• MDR Text Key: 318975849
• Report Number: 3003764610-2023-00015
• Device Sequence Number: 1
• Product Code: ISW
• UDI-Device Identifier: 05690977467873
• UDI-Public: 05690977467873
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/24/2023

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: RKNX230
• Device Catalogue Number: RKNXC230
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 06/26/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other