MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI ; PROSTHESIS, METATARSUPHALANGEAL JOINT, CARTILAGE REPLACEMENT IMPLANT

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

Patient Problems Pain (1994); Weight Changes (2607)

Event Type  Injury  

Event Description

On (b)(6) 2018, i had a cartiva implant on my toe.The pain is progressively getting worse since i had the surgery.It's hard for me to walk or exercise.I have gained weight.I was told my surgery was a failure by my dr.I am refusing to have another surgery at this time, i can't afford to take time off from work or another surgery.The dr told me i would be considered a success because i'm not getting another surgery.This is misleading and very disappointing that the fda would back this product.It should be removed from the market.I have developed pain in my knee and hip being that i am trying to keep weight off my big toe when i walk.Fda safety report id# (b)(4).

• Brand Name: CARTIVA SCI
• Type of Device: PROSTHESIS, METATARSUPHALANGEAL JOINT, CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): CARTIVA, INC.
• MDR Report Key: 8636148
• MDR Text Key: 146104482
• Report Number: MW5086840
• 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: 05/20/2019

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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 56 YR
• Patient Weight: 82