MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Model Number CAR-10-US

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Post Operative Wound Infection (2446)

Event Date 07/16/2019

Event Type  Injury  

Manufacturer Narrative

A review of the quality and manufacturing records for the product lot was conducted and found that the product met all the predefined acceptance criteria for final release.All sterilization records demonstrate the appropriate dose was applied, and all sterilization specifications were met.As the implant was not returned, an assessment of the device could not be carried out.Likewise, additional information regarding the patient's current clinical course was not made available at the time of this report.With the information provided, no definitive root cause could be determined for this event.If additional information is received in the future, this file will be re-opened for assessment/ investigation and updated accordingly.

Event Description

Surgeon feedback received via email communication.The physician reported a cartiva device being implanted on a patient on (b)(6) 2019.Following, a staphylococcus of undetermined origin was found present in the operated area, and the device was removed on (b)(6) 2019.Per the information provided, the patient was treated with a washout and antibiotic cement but has not received a revision.At the present time, no additional information about the patient's current clinical course was made available.

Event Description

Surgeon feedback received via email communication.The physician reported a cartiva device being implanted in a patient on (b)(6) 2019.Following, a staphylococcus infection of undetermined origin was found present in the operated area, and the device was removed on (b)(6) 2019.Per the information provided, the patient was treated with a washout and antibiotic cement but has not received a revision.At the present time, no additional information about the patient's current clinical course was made available.

Manufacturer Narrative

This submission report corrects original patient code and provides additional information for cartiva complaint 19-063, reported on 13-aug-2019 under report number 3009351194-2019-00014.The device was returned for assessment after initial 30-day report.A visual examination of the device returned to cartiva was carried out.The articulating surface of the device exhibited scuffing and smooth, indented areas of wear across the top surface and around the perimeter of the device.The lateral walls of the device exhibited minor scratching.The bottom edge of the device was rough in appearance, with more substantial wear and tags of material present on one half of the perimeter.The device's maximum diameter and height, and weight, were found within the post-sterilization value ranges established through validation of the manufacturing process.

• Brand Name: CARTIVA SCI
• Type of Device: CARTIVA SCI
• Manufacturer (Section D): CARTIVA, INC.; 6120 windward parkway; suite 220; alpharetta GA 30005
• MDR Report Key: 8889564
• MDR Text Key: 154259506
• Report Number: 3009351194-2019-00014
• Device Sequence Number: 1
• Product Code: PNW
• UDI-Device Identifier: 00852897002038
• UDI-Public: (01)00852897002038(10)F062818001(17)2020-07-31
• Combination Product (y/n): N
• PMA/PMN Number: P150017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2020
• Device Model Number: CAR-10-US
• Device Catalogue Number: CAR-10-US
• Device Lot Number: F062818001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/13/2019
• Supplement Dates Manufacturer Received: 07/15/2019
• Supplement Dates FDA Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention