MAUDE Adverse Event Report: CARTIVA, INC CARTIVA IMPLANT 10MM; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT

Model Number CAR-10-US

Device Problem Migration (4003)

Patient Problems Inflammation (1932); Implant Pain (4561)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

The device remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that the patient had a 10mm implant in the first metatarsal of her right foot.The implant has begun to migrate into the next bone.The patient started noticing this issue a year ago.Patient is experiencing a lot of pain and inflammation.

• Brand Name: CARTIVA IMPLANT 10MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14084927
• MDR Text Key: 289081134
• Report Number: 3009351194-2022-00101
• Device Sequence Number: 1
• Product Code: PNW
• UDI-Device Identifier: 00852897002038
• UDI-Public: 00852897002038
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2022

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: Lay User/Patient
• Device Model Number: CAR-10-US
• Device Catalogue Number: CAR-10-US
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/12/2022
• 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
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 113 KG