MAUDE Adverse Event Report: OSSUR ICELAND POWER KNEE G2 KIT; PROSTHETIC KNEE

Model Number PKN120007

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Rupture (2208)

Event Date 08/16/2016

Event Type  Injury  

Event Description

Above knee amputee patient wearing the power knee prosthetic knee fell getting out of his truck in a parking lot.He also fell while walking in the office and he landed on his sound knee.The patient fractured his sound patella.The doctor prescribed medication and rest along with therapy with an orthopedic doctor.The patient is recovering.

Event Description

Above knee amputee patient wearing the power knee prosthetic knee fell getting out of his truck in a parking lot.He also fell while walking in the office and he landed on his sound knee.The patient fractured his sound patella.The doctor prescribed medication and rest along with therapy with an orthopedic doctor.The patient is recovering.

• Brand Name: POWER KNEE G2 KIT
• Type of Device: PROSTHETIC KNEE
• Manufacturer (Section D): OSSUR ICELAND; grjothals 5; reykjavik, 110 ; IC 110
• Manufacturer (Section G): OSSUR ICELAND; grjothals 5; reykjavik, 110 ; IC 110
• Manufacturer Contact: karen montes ; 27051 towne centre drive; foothill ranch, CA 92610 ; 9492757557
• MDR Report Key: 6053963
• MDR Text Key: 58300510
• Report Number: 3003764610-2016-00008
• 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,Followup
• Report Date: 11/03/2016

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: PKN120007
• Device Catalogue Number: PKN120007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2016
• Initial Date FDA Received: 10/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2016
• 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: 61 YR
• Patient Weight: 122