MAUDE Adverse Event Report: CARTIVA, INC CARTIVA IMPLANT; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT

Device Problem Material Deformation (2976)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.

Event Description

Per medwatch mw5098732 it was reported that "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.L'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 IMPLANT
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta GA 30005
• Manufacturer (Section G): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta GA 30005
• Manufacturer Contact: matthew parrish ; 1023 cherry rd; memphis, TN 38117
• MDR Report Key: 11562390
• MDR Text Key: 245127639
• Report Number: 3009351194-2021-00097
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• PMA/PMN Number: P150017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 02/24/2021

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention