MAUDE Adverse Event Report: OSSUR ICELAND POWER KNEE; EXTERNAL ASSEMBLED LOWER LIMB PROSTHESIS

Model Number PKN120007

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problems Fall (1848); Head Injury (1879); Concussion (2192)

Event Date 04/26/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluation anticipated upon receipt of product.

Event Description

Prosthetist reports that the amputee patient fell in his home on tuesday, (b)(6) 2016.Patient was wearing the power knee prosthesis.He was standing on flat ground, not taking a step, and claims it felt like the knee buckled which caused him to lose his balance and fall backwards.The patient hit his head during the fall.No medical attention was sought immediately following the incident.However, the patient recently visited his doctor and was diagnosed with a concussion.

Manufacturer Narrative

Upon product evaluation, it was determined this is not a reportable event.No product malfunction was identified that could have contributed to the incident.

Event Description

Prosthetist reports that the amputee patient fell in his home on tuesday, (b)(6) 2016.Patient was wearing the power knee prosthesis.He was standing on flat ground, not taking a step, and claims it felt like the knee buckled which caused him to lose his balance and fall backwards.The patient hit his head during the fall.No medical attention was sought immediately following the incident.However, the patient recently visited his doctor and was diagnosed with a concussion.

• Brand Name: POWER KNEE
• Type of Device: EXTERNAL ASSEMBLED LOWER LIMB PROSTHESIS
• 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 ; 9493823741
• MDR Report Key: 5680350
• MDR Text Key: 45961808
• Report Number: 3003764610-2016-00006
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2016
• Initial Date FDA Received: 05/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2016
• 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): Other