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

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

Patient Problems Inflammation (1932); Pain (1994); Inadequate Osseointegration (2646)

Event Date 11/15/2018

Event Type  Injury  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

Allegedly it was reported by the patient via fda medwatch report #mw5096706: "i had an issue with my second toe and my foot doctor of 10 years recommended the cartiva joint implant.So on (b)(6) 2018, i had the joint implant done.Not disclosed to me the implant had not been approved by the fda nor by my insurance carrier.For over a year i had been appealing my case to have my claim paid.In the meantime, i have been in pain consistently and my original foot doctor would take xrays and stated my toe was inflamed.This went on and on, then i needed to address my bill again due to carrier not waiting to pay and i took my appeal to upper management with my insurance carrier.Once i did this, i was informed my doctor would not see me again.So i ended up going to another foot doctor to find out what is going on with my toe, after taking x-rays it was determined the cartiva joint implant used for my second toe had absorbed into my bone; which is why i am in pain, my toe is bone on bone.I am now facing another surgery to correct the failed cartiva joint implant that in now absorbed in my toe bone.I did send an email to (b)(6) advising them that this implant failed; but i have not heard back.I did find it strange that when my process of appealing my case, my doctor stated that (b)(6) has offered to contribute towards my bill.I don't want this to happen to other patients; because i have had nothing but severe pain in my foot which radiates up my leg to my hip.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: 10786649
• MDR Text Key: 214608185
• Report Number: 3009351194-2020-00015
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/08/2020

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
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 11/04/2020
• 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