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

Model Number	RKN130003
Health Effect - Clinical Codes	Fall (1848); Rupture (2208)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient fell and suffered a ruptured patella tendon.
Event or Problem Description
The patient was walking in a medical facility for an appointment when he fell.He ruptured his contralateral patella tendon.He had surgery to repair the tendon about 4-5 days after the fall.He is doing fine now.

• 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: 8288246
• Report Number: 3003764610-2019-00003
• Device Sequence Number: 1991810
• Product Code: ISW
• UDI-Device Identifier: 05690967595418
• UDI-Public: 05690967595418
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 02/21/2019

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: 11/27/2018
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 02/21/2019
• 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: Hospitalization