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)

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

Literature citation: akoh et al.Adverse events involving hallux metatarsophalangeal joint implants: comprehensive analysis of us food and drug administration data from 2010 to 2018.Foot & ankle orthopaedics.2020; 5:4.The device was not returned for evaluation.

Event Description

It was reported in a literature article by akoh et.Al.In an article titled, "adverse events involving hallux metatarsophalangeal joint implants: comprehensive analysis of us food and drug administration data from 2010 to 2018" the author did a review of the us food and drug administration's (fda) manufacturer and user facility device experience (maude) database from 2010-2018 to determine reported adverse events for hallux mtpj arthroplasty.Among 64 unique hallux mtpj implant adverse events, the most common modes of failure were component loosening (34%), component fracture (9.4%), inflammation (9.4%), infection (14.1%), and allergic reaction (7.8%).In regards to implant type, synthetic implants (cartiva) had the highest percentage of adverse events (23.4%), followed by arthrosurface toemotion (20.3%), ascension mgt (12.5%), arthrosurface hemicap (10.9%), futura primus (9.4%), and osteomed reflexion (6.3%).

• 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: 11279573
• MDR Text Key: 233360822
• Report Number: 3009351194-2021-00087
• 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