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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 06/13/2019

Event Type  Injury  

Event Description

Had arthritis of great toe.Had cartiva joint implant on (b)(6) 2019.Not too bad for the first 3 months post-op then had severe pain, swelling and difficulty walking.F/u x-ray showed implant had failed causing joint deterioration and developing bone spurs, worsening arthritis, etc., having implant removed and full joint replacement performed to correct the problem.Fda safety report id# (b)(4).

• Brand Name: CARTIVA GREAT TOE JOINT IMPLANT
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): WRIGHT MEDICAL / CARTIVA, INC.
• MDR Report Key: 9286328
• MDR Text Key: 165568721
• Report Number: MW5090913
• 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: 11/01/2019

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Weight: 66