MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. CARTIVA; PROSTHESIS, TOE, HEMI-, PHALANGEAL

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Ambulation Difficulties (2544)

Event Date 01/30/2019

Event Type  Injury  

Event Description

Diagnosed with hallux rigidus on my large right toe i had surgery to remove a bone spur and have cartiva implant to "correct" the arthritic toe joint.After surgery i had less range of motion, a lot more pain, i had to go through physical therapy and i still could not walk without a visible limp, i couldn't stand for very long nor could i walk long distances (around the block) anymore, running was 200% out of the question.At 12 weeks my doctor wanted to re-do the surgery and remove the implant and place cadaver skin in its place.He said the cartiva implant wasn't sitting correctly and causing my toe joint to "jam".I got a second opinion and with that ended up having a second surgery 12 weeks later to remove the cartiva implant and replaced it with arthrosurface.My second doctor said the cartiva was not sitting wrong, it was failing, and i also needed to correct the cause of the bad joint.This doctor also corrected the first metatarsal in my foot which is what caused my arthritis.He showed me pictures of the cartiva after removal and it already had chunks missing, it didn't even hold its shape, it looked like a molar tooth after 12 weeks.I'm still not 100% back to normal nor do i expect i will ever be.I still deal with swelling as my 2nd doctor said i would for a good 9 months to a year (second surgery was on (b)(6) 2019).I can now walk normally (no limp), minimal pain, though i don't have presurgery range of motion, i have decent range of motion and definitely more than with the cartiva and that is without any physical therapy.Fda safety report id # (b)(4).

• Brand Name: CARTIVA
• Type of Device: PROSTHESIS, TOE, HEMI-, PHALANGEAL
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.
• MDR Report Key: 11139143
• MDR Text Key: 226276434
• Report Number: MW5098732
• Device Sequence Number: 1
• Product Code: KWD
• 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: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 77