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

Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta GA 30005
• MDR Report Key: 11279785
• Report Number: 3009351194-2021-00088
• Device Sequence Number: 4188471
• Product Code: PNW
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention