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

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

Patient Problems Inflammation (1932); Pain (1994); Ambulation Difficulties (2544)

Event Date 09/01/2018

Event Type  Injury  

Event Description

I had the cartiva implant in my left first metatarsophalangeal joint (b)(6) 2018 due to diagnosis of hallux rigidus and bone spurs causing pain and limited movement of the toe.My dr recommended cartiva as a better option than fusion as i was only (b)(6) at the time and quite active and desired to retain range of motion of that toe, and this was a recommended procedure to gain back movement while lessening pain.She said that she had done a number of these surgeries with great success.I agreed to the procedure and scheduled surgery.Pain after surgery was worse than prior, as expected with the trauma done to the toe during surgery.However, pain after surgery was gradually decreasing for the next six months through roughly (b)(6) 2018, when i suddenly realized that the pain had stopped decreasing and was in fact increasing again, until the pain was worse than it had been prior to or just after surgery.I was unable to walk comfortably in any shoe and noticeably limped when walking.This was causing add'l pain to develop in other joints like my knees, hips, and back, from walking in an impaired fashion.I went back to my dr to be evaluated and she ordered x-rays which determined that the implant has sunk completely into the bone, which meant that there was no longer anything buffering the two sides of the joint, and the bones were again grinding against each other as the joint moved, which was causing the pain and inflammation i was experiencing.My dr ensured me that she had followed exact procedure by the mfr in placing the implant, and that the x-rays immediately following surgery showed that the implant was properly spaced inside the joint to keep the bones from grinding against each other.She could not offer any thoughts as to why the implant had sunk all the way to the bone, effectively negating the surgery and putting me in a worse place than i was prior to surgery, as prior to surgery i had had a small amount of cartilage left inside the joint, and that was now gone.Required f/u surgery.Fda safety report id# (b)(4).

• Brand Name: CARTIVA SYNTHETIC CARTILAGE IMPLANT
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC. / CARTIVA INC.
• MDR Report Key: 8658430
• MDR Text Key: 146889402
• Report Number: MW5087031
• 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: 05/27/2019

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 82