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 Arthritis (1723); Cyst(s) (1800); Insufficient Information (4580)

Event Date 06/29/2022

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.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.

Event Description

It was reported that, bilateral cartiva implants revised to mtp fusion.

Manufacturer Narrative

Correction b2, h6 clinical.The reported event could be confirmed, since the device was returned indicating a revision surgery was performed.The device inspection revealed the following: the device was returned in a container with a small amount of saline.Device exhibits translucent, whitish hue throughout the body.Visual examination of the implant found the articulating surface to be partially smooth and partially scratched and indented.These indentations also had some material ¿tags¿ around the edges, indicating they could have been caused by more recent damage, such as implant removal.Medical affairs was consulted on the details of this case.Per their review, "this case is about a patient with a longstanding, progressive osteoarthritis of the first mtp-joints (the rigidity coming with that explains the term hallux rigidus) and an interphalangeal hallux valgus on both sides.The latter being corrected with a closing wedge osteotomy of the distal phalanx in both feet, that was stabilized with a small staple.The hallux rigidus was surgically treated with a cartiva implant in the mtp i joints of both feet.The x-ray shows an end-stage osteoarthritis with deformation of the mtp i joint surfaces and a subchondral cyst on the right mtp i joint.Due to the progression of the disease the cartiva implant is not functional any longer.Without further clinical information, this may explain the choice for a fusion of the joint." although the device was returned, the root cause was unable to be determined with the available information.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, bilateral cartiva implants revised to mtp 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: 15108530
• MDR Text Key: 296653987
• Report Number: 3009351194-2022-00106
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• 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
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: No
• 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