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

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

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 10/10/2017

Event Type  Injury  

Manufacturer Narrative

The product was not returned nor were images provided for review; therefore, product analysis cannot be performed.

Event Description

It was reported that the patient underwent a surgical procedure on the left toe.The patient reports having pain and stiffness following the procedure.The patient states, " i had various post checks with physicians assistants who said this was normal and to be patient.She ordered physical therapy for the new troublesome problems i was having with my l toe.She gave me an rx piece of paper for pt.I wheeled on my knee scooter, out to my car and sat to carefully read the pt prescription.There hand written was "l toe cartiva implant".I was confused, so i looked up cartiva on my phone and learned the cartiva was a brand new implant, still undergoing clinical trials in the us and considered experimental in other countries.I continued reading cartiva's web page: if you are considering cartiva, tell your doctor if you have any of the following which could hurt implant success.You have had cancer.I have.You have had chemotherapy.I have, a lot.You have taken steroids.I have.You have poor bone quality.I have osteopenia post chemo.Here, sitting in my car, i developed a sickening sense of betrayal.Why didn't dr.Aminian tell me about the cartiva? i was dumbfounded.In hindsight, i was in a state of shock, numb.I never gave authorization for a cartiva.My pre-op consults were deceptive.Furthermore, he didn't research the exclusion criteria for cartiva.I was not a viable cartiva candidate.

• Brand Name: CARTIVA
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta, ga
• Manufacturer (Section G): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta, ga
• Manufacturer Contact: matthew parrish ; 1023 cherry rd; memphis, tn
• MDR Report Key: 10453961
• MDR Text Key: 204532275
• Report Number: 3009351194-2020-00011
• 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: 07/30/2020

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/26/2020
• 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
• Patient Age: 50 YR