MAUDE Adverse Event Report: WRIGHT MEDICAL / CARTIVA, INC. CARTIVA IMPLANT; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT

Device Problem Failure to Osseointegrate (1863)

Patient Problems Pain (1994); Swelling (2091)

Event Date 11/26/2018

Event Type  malfunction  

Event Description

Had cartiva implant for hallux rigidus.Implant has recessed back into the 1st metatarsal and i am now back to bone on bone with no joint space.Pain and swelling is worse than before the surgery.Facing fusion of great toe.Implant recession noted at 8 week post op appointment.Fda safety report id# (b)(4).Fda received date: 02-aug-2019.

• Brand Name: CARTIVA IMPLANT
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): WRIGHT MEDICAL / CARTIVA, INC.
• MDR Report Key: 8865716
• MDR Text Key: 153856427
• Report Number: MW5088798
• Device Sequence Number: 1
• Product Code: PNW
• 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: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR