MAUDE Adverse Event Report: OSSUR POWER KNEE G2 KIT 2Y WARR; ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXT

Model Number PKN120002

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 05/14/2014

Event Type  Injury  

Event Description

Above knee amputee patient fell while descending a flight of stairs, hit his head and required 7 stitches.

Manufacturer Narrative

• Brand Name: POWER KNEE G2 KIT 2Y WARR
• Type of Device: ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXT
• Manufacturer (Section D): OSSUR; reykjavik ; IC
• Manufacturer Contact: karen montes ; 27051 towne center drive; foothill ranch, CA 92610 ; 9493823741
• MDR Report Key: 4146747
• MDR Text Key: 4928082
• Report Number: 3003764610-2014-00003
• Device Sequence Number: 1
• Product Code: ISW
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2014

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: PKN120002
• Device Catalogue Number: PKN120002
• Device Lot Number: HF510470
• Date Returned to Manufacturer: 06/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2104
• Initial Date FDA Received: 09/23/2014
• 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
• Patient Age: 35 YR
• Patient Weight: 74