MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

The product catalog and lot number of the device involved in this event was not made available.As a result, a review of the quality and manufacturing records for the involved product lot could not be carried out.The patient provided the name of the surgeon involved in this event.The physician was contacted on 03-dec-2019, 10-dec-2019, and, 16-dec-2019 to request product and additional information related to this event and the patient's clinical course.To the present time, the surgeon has not responded to our information requests.Finally, the involved device was not available for evaluation.As a result, no investigation into this occurrence could be performed.If additional information is received in the future, this file will be re-opened for assessment/ investigation and updated accordingly.

Event Description

Feedback from patient received via medwatch report mw5090913.According to their report, the subject received a cartiva implant on (b)(6) 2019.Following, the patient reported continued pain, swelling, and difficulty walking approximately 3 months post surgery.The patient also reported that follow-up electromagnetic images taken of the area suggested an unspecified "implant failure" causing "joint degeneration, worsening of their arthritis condition and development of bone spurs." the subject reported undergoing "implant removal and full joint replacement" on (b)(6) 2019.The product catalog and lot numbers for the involved device were made available.

• 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 alderman drive; suite 208; alpharetta GA 30005
• Manufacturer Contact: pablo mercado ; 6120 windward parkway; suite 220; alpharetta, GA 30005 ; 7707543853
• MDR Report Key: 9503036
• MDR Text Key: 178190073
• Report Number: 3009351194-2019-00028
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2019

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: No Information
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/20/2019
• 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