RHEO KNEE 3 RKN130003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-17 for RHEO KNEE 3 RKN130003 manufactured by Ossur Iceland.

Event Text Entries

[45373369] Claim of above knee amputee patient wearing rheo knee 3 prosthetic knee while in a kitchen. The patient tripped, caught himself and fell over. When the patient impacted, he suffered a broken hip.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3003764610-2016-00005
• MDR Report Key: 5659829
• Date Received: 2016-05-17
• Date of Report: 2016-05-17
• Date Mfgr Received: 2016-05-06
• Date Added to Maude: 2016-05-17
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MRS. KAREN MONTES
• Manufacturer Street: 27051 TOWNE CENTRE DRIVE
• Manufacturer City: FOOTHILL RANCH CA 92610
• Manufacturer Country: US
• Manufacturer Postal: 92610
• Manufacturer Phone: 9493823741
• Manufacturer G1: OSSUR ICELAND
• Manufacturer Street: GRJOTHALS 5
• Manufacturer City: REYKJAVIK, 110
• Manufacturer Country: IC
• Manufacturer Postal Code: 110
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: RHEO KNEE 3
• Generic Name: ASSEMBLY, KNEE LOWER LIMB PROSTHESIS
• Product Code: ISW
• Date Received: 2016-05-17
• Returned To Mfg: 2016-05-17
• Model Number: RKN130003
• Catalog Number: RKN130003
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: OSSUR ICELAND
• Manufacturer Address: GRJOTHALS 5 REYKJAVIK, 110 IC 110

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2016-05-17