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

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Pain (1994)

Event Date 03/29/2018

Event Type  Injury  

Event Description

I had cartiva implant surgery done on (b)(6) 2018.My pain was never relieved and has gotten worse since then.My cartiva is a failure and surgeon says it needs to be removed and my toe needs to be fused.Surgeon took an x-ray on (b)(6) 2019 and deemed the cartiva to be a failure.It had receded in to my bone.Fda safety report id# (b)(4).

• Brand Name: CARTIVA
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): WRIGHT MEDICAL / CARTIVA, INC.
• MDR Report Key: 9008719
• MDR Text Key: 158599371
• Report Number: MW5089746
• 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: 09/09/2019

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 48 YR