MAUDE Adverse Event Report: CARTIVA, INC CARTIVA IMPLANT 10MM; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT

Catalog Number CAR-10-US

Device Problem Migration (4003)

Patient Problems Ossification (1428); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Implant Pain (4561)

Event Date 11/01/2022

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker legal affairs department.No additional information is available currently due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

It was reported that the patient developed pain and mobility issues in right toe.The patient to manage his symptoms, it ultimately became too much.He sought medical evaluation with a podiatrist.Radiological images were obtained showing that the implant had completely subsided down the medullary canal of the first metatarsal.The surgeon advised that because of the failed implant, there was very little conservative treatment that could be offered and recommended surgical removal of the cartiva implant and repair with bone grafting.The surgeon performed the surgery to remove the cartiva implant.When the surgeon encountered the implant, he noted that it was "fully subsided within the first met head.There was no evidence of the implant protruding from the met head.The patient noted that his range of motion had already improved significantly, and he was only experiencing mild pain - a vast improvement.

Event Description

It was reported that the patient developed pain and mobility issues in right toe.The patient to manage his symptoms, it ultimately became too much.He sought medical evaluation with a podiatrist.Radiological images were obtained showing that the implant had completely subsided down the medullary canal of the first metatarsal.The surgeon advised that because of the failed implant, there was very little conservative treatment that could be offered and recommended surgical removal of the cartiva implant and repair with bone grafting.The surgeon performed the surgery to remove the cartiva implant.When the surgeon encountered the implant, he noted that it was "fully subsided within the first met head.There was no evidence of the implant protruding from the met head.The patient noted that his range of motion had already improved significantly, and he was only experiencing mild pain - a vast improvement.

Manufacturer Narrative

Correction d4 lot.The reported event could be confirmed, since medical records received do indicate a revision surgery was performed due to subsidence of the implant into the 1st metatarsal head.Review of provided records finds the patient originally presented with progressive osteoarthritic changes with hypertropy and disability associated with 1st mpj of the right foot.Findings during the implant surgery included, "a significant bony rim was noted around the entire perimeter of the base of the 1st proximal phalanx and dorsal head of the 1st metatarsal.Bony hypertrohy on the dorsal and medial 1st metatarsal head was resected with a power sagittal saw." and "joint surface was inspected and was found that the dorsal half of the 1st metatarsal head was denuded of articular cartilage down to the subchondral bone." cartiva implant was decided necessary and implanted.Three years later, x-rays determined the following, "the implant has subsided down the medullary canal of the first metatarsal.There is bone on bone osteoarthritis of the first mpj with osteophyte formation." the device was implanted for 3 years & 7 months.The ifu states, " risks associated with implantation of hemi-arthroplasty devices or cartiva synthetic cartilage implant include.Pain,.Bone loss,.Implant subsidence, revision or conversion to fusion,.¿ 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 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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: CARTIVA IMPLANT 10MM
• 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: 18360636
• MDR Text Key: 330934704
• Report Number: 3009351194-2023-00020
• Device Sequence Number: 1
• Product Code: PNW
• UDI-Device Identifier: 00852897002038
• UDI-Public: 00852897002038
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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 Expiration Date: 09/30/2020
• Device Catalogue Number: CAR-10-US
• Device Lot Number: F082318002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2018
• 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): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male