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

Device Problems Loose or Intermittent Connection (1371); Unstable (1667); Therapeutic or Diagnostic Output Failure (3023); Noise, Audible (3273)

Patient Problems Arthritis (1723); Failure of Implant (1924); Arthralgia (2355); Inadequate Pain Relief (2388); Joint Laxity (4526)

Event Date 06/23/2021

Event Type  Injury  

Event Description

Preamble i'm a (b)(6) man in good health, about 20 pounds too heavy from my best weight."i'm 5'11" and (b)(6) lbs.About 15 years ago i slipped on ice and broke off about a thumb size piece of the bottom of my fibula in my right leg.At that time it was put back in place and a rigid perforated metal strip with 6 screws was put in to hold it together and in place.Over the years my ankle and foot started hurting.In 2017 i had bone fusion surgery for arthritis and a low arch.I think it involved plates and screws for my navicular, my cuneiform, and my big toe first metatarsal.At that time i also had my two peroneal tendons sewn together because one of them was nearly torn through.Also, she removed the metal strip and screws from my tibia.In (b)(6) 2020 she did my foot arthritis surgery done again, because it was hurting more and more and she said the fusion didn't quite take together like it should have.She took bone from my hip and now that part of my foot feels great.I had all of this done at the va medical center.Then she (the foot surgeon) told me the arthritis pain in and at my ankle called for a prosthetic ankle and she didn't do that type of work.She referred me to (b)(6) hospital on (b)(6).Problem i got a star prosthetic replacement ankle there on (b)(6) 2020 and it went well with no problems with my ankle.My foot still hurt like hell just in front of my ankle.I got a talonavicular fusion on that same (right) foot on (b)(6) 2021 due to arthritis and grinding in that joint.Both were by the same surgeon.I followed doctor's orders and didn't use my foot after that.On (b)(6) i had a post-op appointment for my fusion surgery.At that appointment the surgeon told me to start putting up to about 30% weight on my heel sometimes to get a feel for it, but not to overload it.He also told me to start just working my ankle joint while i was sitting by just pointing the front of my foot down and up over and over.That's when the trouble started.My ankle is starting to hurt and it feels just a little loose and unstable, and it literally squeaks like a rocking chair on old wood floor.This is no exaggeration.If you want to call me i'll squeak it for you and you can hear it over the phone.I don't care that much about how my ankle and foot sound or look.It concerns me that it is getting worse and that it feels slightly like it's just not as solid in the ankle as it was before the foot bone fusion.This may be less of a problem than i'm making it out to be.Maybe the surgeon is still going to fix it.He hasn't "thrown me to the wolves" and we are having more follow-up appointments.Thank you.I'm not complaining about my surgeon.I'm reporting a problem with my 7 month old star ankle replacement ankle.Fda safety report id # (b)(4).

• Brand Name: STAR REPLACEMENT ANKLE
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH
• MDR Report Key: 12226527
• MDR Text Key: 263847512
• Report Number: MW5102775
• Device Sequence Number: 1
• Product Code: NTG
• 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: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 93