MAUDE Adverse Event Report: DEPUY AGILITY SIX ANKLE PROSTHESIS

Device Problems Break (1069); Device Slipped (1584)

Patient Problems Pain (1994); Ulceration (2116); Ambulation Difficulties (2544); Tissue Breakdown (2681); Fluid Discharge (2686)

Event Date 07/07/2006

Event Type  No Answer Provided  

Event Description

I had two failed depuy agility six ankle implants.I had the first implant in (b)(6) 2006.This implant failed due to tilting and slippage of hardware, in particular the talus component.I had considerable pain and disfunction of gait and limited daily living activities.My surgeon and i opted for a second implant revision which took place in (b)(6) 2008, after a three month wait for depuy to complete a custom prosthesis that was submitted by my surgeon.I had problems with this implant-pain gait problems, also removal of plate to check for infection.I had treatment at wound clinics for recurrent skin eruption and drainage on outside of right ankle.I developed an ulcerated spot on my right bottom heel area and after several weeks of wound care it was determined that the talus component had broken and was poking out of my calcaneus into my skin and nerve bundle.I then had a third surgery in (b)(6) 2014 to implant a wright in-bone prosthesis.I am currently recovering from that surgery.I want it noted that depuy received warning letters in (b)(6) 2011 for noncompliance with dea laws regarding testing and marketing of my ankle prosthesis and several other depuy medical devices.This info and other reportage of the depuy agility six ankle performance is available on the dea website.

• Brand Name: AGILITY SIX ANKLE PROSTHESIS
• Type of Device: ANKLE PROSTHESIS
• Manufacturer (Section D): DEPUY
• MDR Report Key: 3845878
• MDR Text Key: 4660258
• Report Number: MW5036402
• Device Sequence Number: 2
• Product Code: HSN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/28/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 59 YR
• Patient Weight: 120