MAUDE Adverse Event Report: OSSUR H/F RHEO KNEE 3 W/LOCK; PROSTHETIC KNEE LOWER LIMB

Model Number RKN13110

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/26/2017

Event Type  Injury  

Event Description

Lower limb amputee patient wearing a rheo knee 3 prosthetic has fallen while walking.According to his statement, he went to the car when he was approached by a friend from the rear left.He turned around while walking and then wanted to continue the step with his prosthesis on the right.However, he just fell into a 'hole' and fell on his femur condyles (knee ex amputated).He describes the situation as that the knee simply was not there as usual.Patient sustained a fractured femur.

Event Description

Lower limb amputee patient wearing a rheo knee 3 prosthetic has fallen while walking.According to his statement, he went to the car when he was approached by a friend from the rear left.He turned around while walking and then wanted to continue the step with his prosthesis on the right.However, he just fell into a 'hole' and fell on his femur condyles (knee ex amputated).He describes the situation as that the knee simply was not there as usual.Patient sustained a fractured femur.

• Brand Name: RHEO KNEE 3 W/LOCK
• Type of Device: PROSTHETIC KNEE LOWER LIMB
• Manufacturer (Section D): OSSUR H/F; grjothals 5; reykjavik, 110 ; IC 110
• Manufacturer (Section G): OSSUR H/F; grjothals 5; reykjavik, 110 ; IC 110
• Manufacturer Contact: karen montes ; 27051 towne centre; foothill ranch, CA 92610 ; 9492757557
• MDR Report Key: 6764679
• MDR Text Key: 81777998
• Report Number: 3003764610-2017-00003
• Device Sequence Number: 1
• Product Code: ISW
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

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: RKN13110
• Device Catalogue Number: RKN13110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2017
• Initial Date FDA Received: 08/03/2017
• Supplement Dates Manufacturer Received: 07/14/2017
• Supplement Dates FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 113