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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 11/01/2018

Event Type  No Answer Provided  

Event Description

I had a cartiva implant (made by wright medical) surgically inserted into my right big toe on (b)(6) 2018.It was touted to be an effective treatment for halux-rigidus - basically arthritis of the big toe.Since the surgery was performed, the pain has only gotten worse.I can barely walk without extreme discomfort in most shoes.A subsequent mri has revealed that the implant has created (in the surgeon's words) a stress reaction in the bone.Fda safety report id# (b)(4).

• Brand Name: CARTIVA IMPLANTS
• Type of Device: PROSTHESIS, TOE, HEMI
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.
• MDR Report Key: 8861270
• MDR Text Key: 153416428
• Report Number: MW5088751
• Device Sequence Number: 0
• Product Code: KWD
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 80