MAUDE Adverse Event Report: OSSUR SYMBIONIC LEG; ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXT

Model Number SMBL3240

Device Problem Fracture (1260)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

Patient (b)(6) was in her backyard and went to take a step with her prosthetic side and the knee bent as she stepped but it did not swing back out.Patient fell and suffered a hip fracture.She has not used the symbionic leg since she fell, but has been in and out of the office and is recovering just fine.

• Brand Name: SYMBIONIC LEG
• Type of Device: ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXT
• Manufacturer (Section D): OSSUR; reykjavik ; IC
• Manufacturer Contact: karen montes ; 27051 towne centre; foothill ranch, CA 92610 ; 9493823741
• MDR Report Key: 4527415
• MDR Text Key: 18086682
• Report Number: 3003764610-2015-00002
• Device Sequence Number: 1
• Product Code: ISW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2015

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: SMBL3240
• Device Catalogue Number: SMBL3240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2014
• Initial Date FDA Received: 02/04/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention