CARTIVA SYNTHETIC CARTILAGE IMPLANT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-30 for CARTIVA SYNTHETIC CARTILAGE IMPLANT manufactured by Wright Medical Technology, Inc. / Cartiva Inc..

Event Text Entries

[146889402] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5087031
• MDR Report Key: 8658430
• Date Received: 2019-05-30
• Date of Report: 2019-05-27
• Date of Event: 2018-09-01
• Date Added to Maude: 2019-05-31
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: CARTIVA SYNTHETIC CARTILAGE IMPLANT
• Generic Name: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE
• Product Code: PNW
• Date Received: 2019-05-30
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: WRIGHT MEDICAL TECHNOLOGY, INC. / CARTIVA INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2019-05-30