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

Model Number CAR-08-AUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

This part is not approved for use in the united states, however, a like device catalog # car-08, 510k # k181348 was cleared in the united states.Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

Allegedly it was reported that the patient underwent a surgical procedure on the toe.It was reported that the patient is in pain which lead to a revision and removal of the implant.During the revision a fusion was performed using an allograft bone graft to fill the voide in combination wit a plate and screws.

• 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: 10812257
• MDR Text Key: 215484457
• Report Number: 3009351194-2020-00016
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2020

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
• Device Model Number: CAR-08-AUS
• Device Lot Number: F022119001
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/09/2020
• 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): Required Intervention