MAUDE Adverse Event Report: WRIGHT MEDICAL / CARTIVA, INC. CARTIVA SYNTHETIC CARTILIAGE IMPLANT; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT

Device Problem Failure to Osseointegrate (1863)

Patient Problem Failure of Implant (1924)

Event Date 10/08/2018

Event Type  Injury  

Event Description

On october 8th i had surgery to implant cartiva to correct hallux rigidus in right big toe.The implant failed and sank into the bone.This required removal and a subsequent fusion surgery.This put me out for months, unable to walk or drive because it was on my right foot.It also meant having to pay for surgery twice.Required second surgery.Fda safety report id # (b)(4).

• Brand Name: CARTIVA SYNTHETIC CARTILIAGE IMPLANT
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): WRIGHT MEDICAL / CARTIVA, INC.
• MDR Report Key: 8865905
• MDR Text Key: 153525703
• Report Number: MW5088807
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 08/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 50 YR