MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI; PROSTHESIS, METATARSOPHALANGEAL JOINT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Inflammation (1932); Pain (1994)

Event Date 08/04/2017

Event Type  Injury  

Event Description

Cartiva implant to correct hallux rigidus, left mtp 1 joint.Joint would only show slow improvement in returning to normal and remained inflamed and very painful.X-rays started to show lucency around the implant at 6 months.Second surgery was performed at 7 months, removing the cartiva implant.The cartiva implant caused dissolving or erosion, or metatarsal bone material around implant.A bone graft had to be performed to repair the largely damaged area where implant was removed.Joint still may require fusion.

• Brand Name: CARTIVA SCI
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT
• Manufacturer (Section D): CARTIVA, INC. ; alpharetta GA
• MDR Report Key: 7337438
• MDR Text Key: 102515816
• Report Number: MW5075848
• 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: 03/12/2018

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 95