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

Model Number CAR-10-US

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 05/08/2019

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.On november 10st, 2020 stryker trauma and extremities acquired cartiva, wright medical, tornier inc.And tornier sas.An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr/vigilance process.

Event Description

It was reported that the patient underwent a surgical procedure.Allegedly, the implant completely subsided and the patient had pain 17 months post-op.The patient underwent a revision surgery.The report describes that the subject responded well to the implant during the first 9 weeks after the procedure, with occasional stiffness and pain occurring during that time.At 10 weeks, the patient described feeling continued pain and soreness related to activity that diminished over the next 10 months.At approximately 13 months, the subject reported pain whenever loading their forefoot.At the time, electromagnetic images showed some loss of the 1st mtp joint space, and ct images showed the implant well placed and progression of the patient's mtp arthritis.Finally, the patient underwent a removal, insertion of bone graft and replacement with a second cartiva device on (b)(6) 2019 to correct subsidence of the first implant.According to the report, the device sat "several millimeters" proud of the first metatarsal head surface.The surgery was completed without issue.No additional information about the patient's current clinical course was made available.

• 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
• Manufacturer (Section G): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta GA 30005
• Manufacturer Contact: matthew parrish ; 1023 cherry rd; memphis, TN 38117
• MDR Report Key: 13606212
• MDR Text Key: 287428519
• Report Number: 3009351194-2022-00053
• Device Sequence Number: 1
• Product Code: PNW
• 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: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2019

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: Health Professional
• Device Model Number: CAR-10-US
• Device Catalogue Number: CAR-10-US
• Device Lot Number: F071317001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female