MAUDE Adverse Event Report: TOTALLY ANKLE REPLACEMENT STAR; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Approximately 2 years ago i had a total ankle replacement manufactured by star.For pain in left ankle from break about 7 years ago.After ankle replacement pain went from when i used it to now when it hurts most all the time.When i relax it then try to walk pain is unbearable.The doctor (b)(6) m.D.Wanted to do surgery again, i decided i would not take the chance of letting him touch it again.It hurts bad but i can still somewhat walk with pain better, then not walking at all.On medicare now and can't afford to have it repaired.It's also causes a type of growth on bottom of foot.Went to foot doctor about a year ago and was told it was a common problem from that type of surgery.Only thing that they can do for it was an insert in shoe to relieve some pressure from foot that would relieve some pain.It depressed me that i had surgery in first place i've not returned to any doctor since.As a foot note so many dumb (b)(6) killed them selfs with pain pills going to a pain management dr is like going to see a parole officer.You get third degree and their afraid they will be sued or lose their license.Anyone that goes to a pain management dr will tell you it's hard to feel sorry for the (b)(6) that odd and causing you pain.Fda safety report id # (b)(4).

• Brand Name: TOTALLY ANKLE REPLACEMENT STAR
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• MDR Report Key: 14624012
• MDR Text Key: 293707927
• Report Number: MW5110158
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White