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

Model Number	RKN130003
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient fell and broke her arm.
Event or Problem Description
The patient fell and broke her arm.

• Brand Name: RHEO KNEE 3
• Common Device Name: PROSTHETIC KNEE
• Manufacturer (Section D): OSSUR HF; grjothals 1-5; reykjavik, 110 ; IC 110
• MDR Report Key: 8394294
• Report Number: 3003764610-2019-00005
• Device Sequence Number: 11454439
• Product Code: ISW
• UDI-Device Identifier: 05690967595418
• UDI-Public: 05690967595418
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other