MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA IMPLANTS; PROSTHESIS, TOE, HEMI

Device Problem Failure to Osseointegrate (1863)

Patient Problems Failure of Implant (1924); Pain (1994); Swelling (2091)

Event Date 12/08/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, i had bilateral toe surgery to place cartiva implants in my great toes due to severe hallux rigidus.The surgery was performed by dr (b)(6) in (b)(6).I diligently went through physical therapy.I followed-up with dr (b)(6) on two separate occasions in 2018 due to pain in my toes, lack of balance and rigidity in my toes.Each time, i had x-rays and was told that i was still swollen and healing." on (b)(6) 2019 i returned to dr (b)(6) for my one year f/u.I had repeat x-rays and was told that both cartiva implants had failed.They had receded and both toe joints are "bone-on-bone." dr (b)(6) informed me at this appt that he no longer performs the cartiva implant surgery due to its high failure rate, which he claimed is around 50% and not the 90% success rate claimed by the cartiva company.Both x-rays revealed the cartiva implants had recessed.Fda safety report id# (b)(4).

• Brand Name: CARTIVA IMPLANTS
• Type of Device: PROSTHESIS, TOE, HEMI
• Manufacturer (Section D): CARTIVA, INC.
• MDR Report Key: 8856813
• MDR Text Key: 153498944
• Report Number: MW5088686
• Device Sequence Number: 2
• Product Code: KWD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/29/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 47 YR
• Patient Weight: 59