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

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

Patient Problems Arthritis (1723); Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544)

Event Date 05/21/2018

Event Type  Injury  

Event Description

I had the cartiva implant on my right big (1st) toe to help with extreme pain and arthritis in that toe.I went to dr (b)(6) with (b)(6) orthopedics.After evaluating my toe, he said i have arthritis on the 1st mtp joint, 1st proximal phalanx dorsal bone spur.Dr (b)(6) recommended surgery - right hallux cheilectomy and cartiva implant insertion.I had this surgery on (b)(6) 2018.Since this surgery, i have experienced more pain from my big toe than i had prior to surgery.I have no range of motion after months of physical therapy on the toe, use of a dynasplint on the toe and several f/u visits with dr (b)(6).The cartiva implant has caused me to walk with a limp, and i did not have a normal quality of life because of this surgery and implant.Fda safety report id# (b)(4).

• Brand Name: CARTIVIA IMPLANT
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): WRIGHT MEDICAL / CARTIVA, INC.
• MDR Report Key: 9818042
• MDR Text Key: 183347716
• Report Number: MW5093656
• 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: 03/08/2020

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 54