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

Device Problem Migration (4003)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

Literature citation: kevin rosas et al.Early failures of polyvinyl alcohol hydrogel implant for the treatment of hallux rigidus.Foot & ankle orthopaedics.2020; 5:4.The device was not returned for evaluation.

Event Description

It was reported in a literature article by rosas et al.Titled, "early failures of polyvinyl alcohol hydrogel implant for the treatment of hallux rigidus" that 15 patients following a polyvinyl alcohol hydrogel implant for the treatment of hallux rigidus.Of 14 patients who had taken adequate postoperative plain radiographs, implant subsidence was observed in 9 patients (64%) at 4 weeks after surgery and 11 patients (79%) at final follow-up.Eight patients (57%) showed radiologic lucency around the implant.Six patients (40%) had erosion of the proximal phalanx of great toe.Six patients (43%) reported no improvement following surgery at final follow up.Three patients required additional surgery, including debridement and fixation of implant using fibrin glue for loosening.

• Brand Name: CARTIVA IMPLANT
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta GA 30005
• Manufacturer (Section G): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta GA 30005
• Manufacturer Contact: matthew parrish ; 1023 cherry rd; memphis, TN 38117
• MDR Report Key: 11279220
• MDR Text Key: 230274402
• Report Number: 3009351194-2021-00085
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention