MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032)

Event Date 02/13/2019

Event Type  Injury  

Manufacturer Narrative

The involved surgeon was contacted to request product catalog and lot number, and additional information regarding the involved patient's clinical course.As the physician has not provided product information, patient clinical course or assessment, nor details regarding the removal and revision performed on the patient, a review of the quality and manufacturing records for the involved implant lot could not be carried out, nor a patient impact assessment could be performed prior to this report.At the present time, the event could not be definitely confirmed.Should additional details be provided in the future, an update to this submission will be provided.

Event Description

Feedback received via medwatch report mw5087031.According to the information received, a patient reported having received a cartiva implant in their left mtp toe.Following, the patient experienced "pain (that) had stopped decreasing and was in fact increasing" six months postoperative, which made them "unable to walk comfortably in any shoe and limping while walking".The patient expressed that electromagnetic images taken by the involved surgeon showed the implant had subsided "to the bone" causing "pain and inflammation", requiring 'follow-up surgery (i.E., revision).".

• 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: tanya eberle ; 6120 windward parkway; suite 220; alpharetta, GA 30005 ; 7707543814
• MDR Report Key: 8780575
• MDR Text Key: 150705443
• Report Number: 3009351194-2019-00010
• 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: 07/11/2019

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: 06/13/2019
• Initial Date FDA Received: 07/11/2019
• 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