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

Model Number CAR-10-US

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

Patient Problems Erosion (1750); Pain (1994)

Event Date 11/06/2020

Event Type  Injury  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

Allegedly it was reported that the patient underwent bilateral 10-mm sci implantation, with care taken to maintain the implant 2 mm proud.Initial postoperative course was unremarkable, with the exception of a left second metatarsal shaft fracture sustained when she inadvertently stepped on a piece of wood.Radiographs from this time demonstrated joint space loss.Two year follow-up radiographs demonstrated progressive deterioration of the left hallux mtp joint with shortening of the hallux and an elevatus deformity.Bilateral conversion to fusion without incident.Evaluation of the left hallus demonstrated severe erosive wear of the implant, bone loss of the proximal phalanx, and erosion of the subchondral plate with exposure of underlying trabecular bone.The implant was well fixed and there were no signs of infection.

Manufacturer Narrative

H6: the product was not returned for review.Image of the explanted device for the left foot shows implant in translucent appearance and with significant material loss on the articulating surface.Exact dimensions and joint conditions are difficult to assess from the intraoperative images due to lighting and resolution limits.There was no image of the explanted device used on the right foot.

Event Description

Allegedly it was reported that the patient underwent bilateral 10-mm sci implantation, with care taken to maintain the implant 2 mm proud.Initial postoperative course was unremarkable, with the exception of a left second metatarsal shaft fracture sustained when she inadvertently stepped on a piece of wood.Radiographs from this time demonstrated joint space loss.Two year follow-up radiographs demonstrated progressive deterioration of the left hallux mtp joint with shortening of the hallux and an elevatus deformity.Bilateral conversion to fusion without incident.Evalution of the left hallus demonstrated severe erosive wear of the implant, bone loss of the proximal phalanx, and erosion of the subchondral plate with exposure of underlying trabecular bone.The implant was well fixed and there were no signs of infection.

• Brand Name: CARTIVA IMPLANT
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta GA 30005
• MDR Report Key: 11008360
• MDR Text Key: 221493790
• Report Number: 3009351194-2020-00018
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• PMA/PMN Number: K181348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: CAR-10-US
• Device Catalogue Number: CAR-10-US
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 11/18/2020
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR