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

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

Patient Problems Pain (1994); No Code Available (3191)

Event Date 01/24/2019

Event Type  Injury  

Event Description

I had bilateral cartiva implants placed in great toes bilaterally and bone spurs removed on (b)(6) 2019.I went through physical therapy after my surgery.I still was having pain in my great toe joints after returning to work after surgery, but was told may take 6 months to heal.The pain in my great toe joints seemed to be getting worse and not better.I talked with my dr about this and followed up in his office on (b)(6) 2019.X-rays were done and found that the cartiva implants had failed and i no longer had any space in the joint.I was told that i will need to have the cartiva implants removed and different implants inserted.I am a nurse who works full time and on my feet constantly for 9 hrs shifts at a time.I have significant pain every day.I am having surgery on (b)(6) 2019 to have the cartiva removed.I would have the surgery sooner but it is a very busy time at work.I work in outpatient surgery and i am waiting to take off work after the holidays and to build my time-off back up since i was off for 6 weeks after the first surgery.Had to have another surgery.After having cartiva implants placed, i haven't been able to run anymore because my feet are too uncomfortable.Fda safety report id# (b)(4).

• Brand Name: CARTIVA IMPLANT
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): CARTIVA, INC.
• MDR Report Key: 9286170
• MDR Text Key: 165553118
• Report Number: MW5090909
• 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?: 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: 11/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 100