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

Catalog Number CAR-10

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

Patient Problems Osteolysis (2377); Insufficient Information (4580)

Event Date 01/11/2022

Event Type  Injury  

Manufacturer Narrative

Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

Event Description

It was reported that patient underwent a revision surgery to have the cartiva device removed and converted to a mtp1 fusion.

Manufacturer Narrative

Correction: g1 manufacturing site, h6 clinical, d4 part number and gtin the reported event could be confirmed, since the device was returned for evaluation confirming a revision surgery was performed.The device inspection revealed the following: the device was returned without any liquid, enclosed in a medical sample cup, and packed in a zip-lock pouch.The device had a yellow-ish hue, was translucent throughout its length, and was stiff to touch.The sides of the implant had dark red-brown spots.Upon visual examination, the articulating surface of the implant has a curved indentation with a consistent radius.One edge of the articulating top surface has irregular wear with a rough finish, and it's asymmetrical compared to the other side of the implant.The device was left in sterile saline over 8 days.After hydration, the device became more elastic.The diameter and height of the returned device were measured on a calibrated optical comparator at three different orientation and weighed three times on a calibrated scale, both before and after hydration.The height and diameter of the hydrated returned device are within the sterile specification for freshly manufactured car-10 device (9.45 mm returned vs 9.0-10.3 mm height specification) (10.33 mm returned vs 10.2-11.0 mm diameter specification).The wear observed on the edge of the articulating top surface is asymmetrical compared to the other side and has a rough surface finish.This is not consistent with the wear observed in the cartiva on cartilage wear study simulating 5 years of use.No further conclusion can be drawn without knowing the condition of the opposing cartilage / joint.No root cause of device removal can be determined due to the dehydration process that the returned device experienced.Our medical affairs contact reviewed the available information and provided imaging.Per their review, "the x-ray show extensive joint space narrowing and subchondral osteolysis in the head of the first metatarsal and in the proximal phalanx.This indicates end-stage osteoarthritis with involvement of the whole joint.In these circumstances the cartiva implants articulates with the rough surface of the proximal phalanx, explaining the roughening of this side of the cartiva implant.The osteoarthritic deformity of the mtp i joint causes subluxation, explains for the asymmetrical wear of the distal side of the implant.This case could be assessed in more detail if the pre-operative and early postoperative x-rays would come available." more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that patient underwent a revision surgery to have the cartiva device removed and converted to a mtp1 fusion.

• Brand Name: CARTIVA SYNTHETIC CARTILAGE IMPLANT
• 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: 13486166
• MDR Text Key: 287426769
• Report Number: 3009351194-2022-00001
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 06/07/2022

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CAR-10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 05/12/2022
• Supplement Dates FDA Received: 06/07/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female