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

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

Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032)

Event Date 01/08/2020

Event Type  Injury  

Event Description

Pain; i had a bone spur and severe pain in right great toe.I had the spur removed and a cartiva joint implant.This did not help with the pain or limited motion of the toe.It caused increased swelling and absolutely no improvement.I now have to have more surgery and possible joint fusion to alleviate the constant pain in my toe.Fda safety report id# (b)(4).

• Brand Name: CARTIVA
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.
• MDR Report Key: 12525675
• MDR Text Key: 273380100
• Report Number: MW5104183
• Device Sequence Number: 1
• Product Code: PNW
• 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: 09/22/2021

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: 09/23/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 66 YR
• Patient Weight: 52