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

Model Number SMBL2240

Device Problem Fracture (1260)

Patient Problems Death (1802); Fall (1848); Bone Fracture(s) (1870); Pneumonia (2011)

Event Type  Injury  

Event Description

Prosthetic patient was walking using a symbionic leg and fell which resulted in a broken hip.

Manufacturer Narrative

Patient subsequently passed away from pneumonia.

• 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: 4516630
• MDR Text Key: 5443304
• Report Number: 3003764610-2015-00004
• 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: 02/05/2015

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: SMBL2240
• Device Catalogue Number: SMBL2240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2015
• Initial Date FDA Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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