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

Device Problem Migration (4003)

Patient Problems Pain (1994); Sleep Dysfunction (2517); Swelling/ Edema (4577)

Event Date 08/15/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.

Event Description

It was reported that the patient underwent a surgical procedure on the right big toe to treat hallux rigidus.Allegedly, after 4 months the patient was told that the implant had failed and the patient would need to undergo a revision surgery.The patient was in excruciating pain and underwent a revision to remove the implant and an alternate procedure to treat the hallux rigidus.During the revision it was discovered that the implant receded into the bone.The patient reported that following the original procedure she was not able to participate in normal outdoor activities nor was she able to exercise.Most of the time was spent icing and resting to mitigate the toe pain.The patient also reports having difficulty sleeping and becoming excessively nervous and anxious.Could not do typical chores around the house.

• 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: 11684926
• MDR Text Key: 262700904
• Report Number: 3009351194-2021-00101
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2021
• Initial Date FDA Received: 04/19/2021
• 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