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

Model Number 10MM

Device Problem Noise, Audible (3273)

Patient Problems Edema (1820); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Discomfort (2330)

Event Date 12/21/2018

Event Type  Injury  

Event Description

Due to osteoarthritis, i developed hallux rigidus of my left foot mtp joint.Conferred with podiatric surgeon, tried conservative measures (corticosteroid injection, using a carbon-fiber shoe insert), and then agreed to have a surgery which included a cheilectomy, and cartiva (10mm) implant.Date of surgery was (b)(6) 2018.X-rays were taken immediately following surgery while in the recovery room.Implant was well-placed, and appropriate spacing in between joints showed effective spacing.Sutures were removed on (b)(6) 2019, the incision was completely healed.There was minimal edema to the mtpj.I was able to wear normal flat shoes, while wearing a compressive sock.The next f/u appt was on (b)(6) 2019.I told the dr that my foot was uncomfortable about half of the time, that i had felt a sudden shooting pain at one point, and that i could sometimes feel a clicking inside the toe joint.I continued to wear the compression sock for midfoot and joint swelling.I had more x-rays taken on the same day, immediately after my surgeon's appt.Radiology findings were: "increased lucency at the site of implant placement to which attention on f/u is recommended." next f/u was on (b)(6) 2019.I had a new x-rays taken on (b)(6) 2019.I was continuing to experience pain (now including the hallux ipj) and swelling.I was still feeling a clicking sensation in the joint.Radiology findings were: "there is loss of first mtpj joint space when compared to immediate postoperative films.Slight elevation of the first metatarsal head".The dr gave me a prescription for voltaren gel to be used topically as needed, and a referral to physical therapy.I was getting sudden shooting pains in the left foot and by now my gait had been affected - resulting in ongoing left knee pain, and lower back pain as well.I was having shooting pain in my foot several times a day, and was now walking on the outside of my foot due to non-stop pain and loss of range of motion.I went to physical therapy for 12 visits during a 2 month span of time.I performed all of the recommended exercises at home.We ended physical therapy as there seemed to be no point - i was still in a lot of pain and wasn't gaining any range of motion.Mri findings taken on (b)(6) 2019 were: "there is prominent marrow edema within the first metatarsal and first proximal phalanx.This may be secondary to postsurgical change or mechanical stress.There is no effusion within the first mtp joint.There is irregularity of both sesamoid bones at the first metatarsal head which also demonstrate increased marrow edema." next appt with podiatric surgeon was on (b)(6) 2019."clinical radiographic findings were discussed with the pt.Pt continues to note limitations with activities despite multiple conservative efforts to improve first mtpj range of motion and decreased pain.Today we discussed revisional surgery in the form of a first mtpj fusion.This would likely involve the use of autogenous bone graft from the heel versus allogeneic bone graft.I informed pt that fusing the first mtpj would help decrease pain to the forefoot and allow her to resume a more normal gait pattern with hopes of decreasing stress on the knee and lower back.".

• Brand Name: CARTIVA IMPLANT
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): CARTIVA, INC. / WRIGHT MEDICAL INC.
• MDR Report Key: 9082504
• MDR Text Key: 159402310
• Report Number: MW5089870
• 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?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2020
• Device Model Number: 10MM
• Device Lot Number: F052418001
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 58 YR
• Patient Weight: 98