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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Unspecified Infection (1930); Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 07/22/2019

Event Type  Injury  

Event Description

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 IMPLANT
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): CARTIVA, INC.
• MDR Report Key: 10173604
• MDR Text Key: 195941408
• Report Number: MW5095070
• 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: 06/16/2020

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/18/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 32 YR
• Patient Weight: 73