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 Unspecified Infection (1930); Pain (1994)

Event Date 02/17/2020

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 in medwatch report mw5095070: "i had a cartiva implant placed in my big toe.Device caused massive infection which placed me in hospital for a week.Over a year and a half of pain after and apparently nothing wrong with the implant, i went to another doctor and begged for him to remove the foot.The device had failed.My joint was destroyed, i had to have my toe rebuilt and fused.Fda safety report id# (b)(4).".

• 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: 10449601
• MDR Text Key: 204273438
• Report Number: 3009351194-2020-00010
• 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: 07/29/2020

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: 07/29/2020
• Initial Date FDA Received: 08/25/2020
• 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