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

Catalog Number CAR-08

Device Problem Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 08/05/2022

Event Type  Injury  

Event Description

It was reported "a failed cartiva implant which was revised".Surgeon expressed concern "as the implant had been in for less than 12 months and showed signs of significant wear".

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.

Manufacturer Narrative

The reported event could not be confirmed since the device was returned in a state that made evaluation impossible.Based on information obtained, the implant was autoclaved by the hospital which destroyed the normal characteristics of the device.Therefore, no inspection could be performed.Images provided do appear to show slight uneven wear; however, this cannot be confirmed based on the imaging alone.Medical affairs was consulted regarding the available information of this case.It was noted, ".The indication for the primary surgery was osteoarthritis with wear of a large area of the mt i head articular surface beforehand.The most cartilage seems be lost at the dorsal side of the metatarsal head, that is the ¿upper side¿ of the mt head in this position on the photograph.This area transfers the higher stresses, and that will also be the case when a cartiva implant is being implanted in that area.Therefore, i am not surprised to see this change in geometry in the dorsal side of the implant.Whether it is plastic deformation, asymmetric volumetric wear, or a combination of those is not clear from these pictures alone." it was also noted in op notes provided by the initial reporter that the device was not obviously loose and no evidence of subsidence.Based on the information provided and the results of the investigation, the root cause was attributed to a patient-factors related issue.The failure was caused by an existing patient condition which placed additional load on the dorsal side of the implant while in-vivo.A review of the device history for the reported lot did not indicate any abnormalities.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 more information is provided, the case will be reassessed.

Event Description

It was reported "a failed cartiva implant which was revised".Surgeon expressed concern "as the implant had been in for less than 12 months and showed signs of significant wear".

• 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: 15327393
• MDR Text Key: 298968537
• Report Number: 3009351194-2022-00110
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P150017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: CAR-08
• Device Lot Number: F020421002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 10/25/2022
• Supplement Dates FDA Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/04/2021
• 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