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

Device Problem Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 12/07/2018

Event Type  Injury  

Manufacturer Narrative

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

It was reported by the patient in fda medwatch report #mw5094393: "surgery to remove failed device; surgeon install the device on left mtp joint.The joint never recovered.The pain never decreased.Had a recent x-ray that showed the joint was back to the pre-surgery state of bone-on-bone.Fda safety report id# (b)(4)." no product nor surgeon information was provided.

• Brand Name: CARTIVA SCI
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta, ga
• Manufacturer (Section G): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta, ga
• Manufacturer Contact: matthew parrish ; 1023 cherry rd; memphis, tn
• MDR Report Key: 10145590
• MDR Text Key: 195126106
• Report Number: 1043534-2020-00120
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 05/15/2020

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 06/11/2020
• 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): Other