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

Catalog Number CAR-10-AUS

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

Patient Problems Cyst(s) (1800); Pain (1994)

Event Date 04/07/2021

Event Type  Injury  

Manufacturer Narrative

Device not returned at the time of this report.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that the patient had continual pain at the first mtp joint and underwent a revision surgery to remove the toe implant.During the revision it was found that the implant had significant wear on the articulating surface.It was also reported that the patient had a large cyst formed beneath the implant.In the revision surgery, the surgeon used bone graft to fill the void and inserted a mtp plate with screws for arthrodesis.

Manufacturer Narrative

Please note corrected data in d9.The reported event could be confirmed, since images provided indicate removal of the implant due to pain.Based on investigation, the root cause was attributed to a patient factors related issue.The failure was caused by pain and cystic changes in the patient's first metatarsal bone.There are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.The current package insert provided with these devices states, "an implant site may become infected, painful, swollen, or inflamed.Risks associated with implantation of hemi-arthroplasty devices or cartiva synthetic cartilage implant include bony reaction, implant loosening, implant dislocation/dislodgement, cysts, bony erosion, and device wear." the device had been implanted for approximately 2.5 years.Our medical professional confirmed there are clear signs of cystic changes in the first metatarsal bone, which was also confirmed during the revision surgery.While this is a known adverse event after cartiva implantation, the root cause is not entirely clear.Some reports relate this adverse event to biocompatibility issues, an inflammatory reaction in the body most probably caused by the material.Whether that was the case for this patient can only be confirmed by the pathologist checking of the tissues/ bone which may have been removed and send for investigation.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that the patient had continual pain at the first mtp joint and underwent a revision surgery to remove the toe implant.During the revision it was found that the implant had significant wear on the articulating surface.It was also reported that the patient had a large cyst formed beneath the implant.In the revision surgery, the surgeon used bone graft to fill the void and inserted a mtp plate with screws for arthrodesis.

• Brand Name: CARTIVA
• 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: 11769193
• MDR Text Key: 248780545
• Report Number: 3009351194-2021-00113
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• PMA/PMN Number: P150017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

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: Lay User/Patient
• Device Catalogue Number: CAR-10-AUS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 07/12/2021
• Supplement Dates FDA Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention