MAUDE Adverse Event Report: OSSUR H/F SYMBIONIC KNEE; PROSTHETIC KNEE

Model Number SMBE7280

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Date 08/29/2017

Event Type  Injury  

Event Description

Amputee patient fell while wearing a prosthetic knee and incurred a broken toe on sound side.

• Brand Name: SYMBIONIC KNEE
• Type of Device: PROSTHETIC KNEE
• 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: 6976631
• MDR Text Key: 90234247
• Report Number: 3003764610-2017-00004
• 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
• Type of Report: Initial
• Report Date: 10/25/2017

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: SMBE7280
• Device Catalogue Number: SMBE7280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 10/25/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention