MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Model Number CAR-10-US

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671)

Event Date 10/19/2018

Event Type  Injury  

Event Description

According to the information provided by the involved surgeon, a patient received a cartiva implant in her right mtp on (b)(6) 2018.Following, the implant was removed and replaced with another cartiva device on (b)(6) 2018 after the patient reported continued pain and the mtp joint appeared immobile and uncapable of bearing weight.

Event Description

According to the information provided by the involved surgeon, a patient received a cartiva implant in her right mtp on (b)(6) 2018.The patient reported continued pain and immobility.The implant was removed and the patient underwent revision to arthroplasty on (b)(6) 2018.

Manufacturer Narrative

This submission report corrects original event description provided for cartiva complaint (b)(4).At the time of original report submission, it was stated that the patient had received a second cartiva device as replacement.Feedback received from the involved surgeon after submission of this event noted that the patient underwent an arthroplasty instead.This correction updates the original submission.Note: this correction does not affect the outcome and results of the investigation, nor the event problem and evaluation codes attributed to this event.

• Brand Name: CARTIVA SCI
• Type of Device: CARTIVA SCI
• Manufacturer (Section D): CARTIVA, INC.; 6120 windward parkway; suite 220; alpharetta GA 30005
• Manufacturer (Section G): CARTIVA, INC.; 1005 alerman drive; suite 208; alpharetta GA 30005
• Manufacturer Contact: tanya eberle ; 6120 windward parkway; suite 220; alpharetta, GA 30005 ; 7707543814
• MDR Report Key: 8034835
• MDR Text Key: 126008049
• Report Number: 3009351194-2018-00009
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

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 Model Number: CAR-10-US
• Device Catalogue Number: CAR-10-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 11/02/2018
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 56 YR
• Patient Sex: Female