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

Device Problem Break (1069)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 10/10/2017

Event Type  Injury  

Event Description

Had cartiva implant placed in right toe joint.Immediately after surgery, had a staff infection wet in.About 2-3 weeks after surgery pain in joint got worse.Dr finally realized the implant had broken and had to be removed.Patient has photos, and x-rays.Needed to have second surgery.Fda safety report id # (b)(4).

• Brand Name: JONT REPLACEMENT
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): CARTIVA INC.
• MDR Report Key: 8869181
• MDR Text Key: 153712483
• Report Number: MW5088853
• 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: 08/05/2019

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 46 YR
• Patient Weight: 95