MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. /CARTIVA INC CARTIVA SYNTHETIC CARTILAGE IMPLANT (CARTIVA SCI).; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT

Device Problems Malposition of Device (2616); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2020

Event Type  Injury  

Event Description

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 implants are failing despite research by judith f.Baumhauer 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 this research and i believe these findings are totally incorrect and misleading.Many podiatry offices are no longer offering cartiva based on the terrible results.More research should have been done prior to approval.A summary 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 me that the implant sunk into the bone.I feel that the surgeon is not to blame for this and i am a strong athletic male and my bone is not to 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 id # (b)(4).

• Brand Name: CARTIVA SYNTHETIC CARTILAGE IMPLANT (CARTIVA SCI).
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC. /CARTIVA INC
• MDR Report Key: 10257375
• MDR Text Key: 198505793
• Report Number: MW5095462
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• 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: 07/07/2020

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: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 68