MAUDE Adverse Event Report: OSSUR HF RHEO KNEE 3; PROSTHETIC KNEE

Model Number RKN130003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

The patient fell and broke her arm.

Event Description

The patient fell and broke her arm.

• Brand Name: RHEO KNEE 3
• Type of Device: PROSTHETIC KNEE
• Manufacturer (Section D): OSSUR HF; grjothals 1-5; reykjavik, 110 ; IC 110
• MDR Report Key: 8394294
• MDR Text Key: 137945790
• Report Number: 3003764610-2019-00005
• Device Sequence Number: 1
• Product Code: ISW
• UDI-Device Identifier: 05690967595418
• UDI-Public: 05690967595418
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RKN130003
• Device Catalogue Number: RKN130003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Date Manufacturer Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other