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

Device Problems Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Literature citation: metikala et al.Adverse events related to polyvinyl alcohol hydrogel hemiarthroplasty of 1st metatarsal: an analysis of reports to the united states food and drug administration.Foot & ankle orthopaedics.2020; 5:4.The device was not returned for evaluation.

Event Description

It was reported in a literature article by metikala el al.Titled adverse events related to polyvinyl alcohol hydrogel hemiarthroplasty of 1st metatarsal: an analysis of reports to the united states food and drug administration did a retrospective review of maude database between july 2016 and october 2019 using the assigned product code: pnw for the polyvinyl alcohol hydrogel implant.A total of 49 events have been reported to this voluntary database over the past 3 years while over 22,000 cartiva devices have been implanted.Implant subsidence was the most common with 16 reported instances.Fragmentation of the device was observed in nine and four reports were related to infection in which two were deep infections needing antibiotic spacers.Bone erosion managed by grafting was documented in three reports and foreign body reaction was noted in one.Persistent pain and swelling were common presentations.Thirty-five of 49 reported events required additional operative procedures performed at a mean interval of 4.75 months following the index procedure while four more were awaiting further surgery.Conversion to fusion was the most common procedure, featured in 10 reports.

• 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: 11279785
• MDR Text Key: 231133383
• Report Number: 3009351194-2021-00088
• 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?: Yes
• 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