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

Device Problem Migration (4003)

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

Event Date 03/11/2020

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 per medwatch mw5095462 "on (b)(6) 2019 i had a cartiva implant placed in my left toe , follow up with my doctor revealed a failed implant approximately a year later which required revision surgery.It seems that a great number of these implant are falling despite research by judith f.Baumher and others which showed only 11% which greatly differs from what podiatrists are seeing in the us now with a high percentage failure rate.I based my decision for cartiva based on the research and i believe the findings are totally incorrect and misleading , many podiatry office are no longer offering cartiva based on the terrible results more research should have been done prior to approval.A summery of why cartiva fails can be found here (b)(6).I had to have revision surgery to a fusion on (b)(6) 2020 due to failure and a worsening of my great toe arthritis on my last appointment.My podiatrist told to me that the implant sunk into the bone.I feel that surgeon is not to be blame for this a and i am a strong athletic male and my bone os not to be blame.The design of the implant is to blame.I would advise removing this device for approval, as it doesn't work fda safety report.".

• 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: 10524615
• MDR Text Key: 206744199
• Report Number: 3009351194-2020-00012
• 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: 08/18/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/11/2020
• 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