MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. CARTIVA IMPLANT; PROSTHESIS, TOE, HEMI

Device Problem Defective Component (2292)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 05/03/2018

Event Type  malfunction  

Event Description

Received a cartiva joint replacement implant in my left big toe to help resolve hallux rigidus.In more than a year post-surgery, my pain has increased to levels worse than it was before surgery.Received a second opinion from another surgeon who stated that the joint space has decreased significantly and she recommends removing the cartiva implant and replacing it with a hemicap implant.She mentioned she sees a lot of failed cartiva implants.Surgery to remove cartiva and replace it with hemicap scheduled for (b)(6) 2019.Fda safety report id # (b)(4).

• Brand Name: CARTIVA IMPLANT
• Type of Device: PROSTHESIS, TOE, HEMI
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.
• MDR Report Key: 8861289
• MDR Text Key: 153842932
• Report Number: MW5088752
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 60