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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 02/15/2019

Event Type  Injury  

Event Description

On the above date, i underwent placement of a cartiva mtp joint implant.Approximately 6-8 weeks later, i developed severe pain in the area.I went to my podiatrist, who confirmed by x-ray that the implant had receded into the bone (failed).At this point i had already returned to work.I had to continue to work as a emergency department rn (walking approximately 4-6 miles per day) to accrue enough pto to have the implant removed & mtp joint fused july 18th.My orthopedic surgeon states the implant had "fallen apart".Because of this failure, i'm non weight-bearing for the next six weeks and unable to perform the functions of my job for the next 8-12 weeks.I would urge the fda to consider further testing of this device, as i believe the failure rate has been underreported.Fda safety report id # (b)(4).

• Brand Name: CARTIVA SCI
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT, CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): WRIGHT MEDICAL GROUP / CARTIVA, INC
• MDR Report Key: 8861215
• MDR Text Key: 153393357
• Report Number: MW5088744
• 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: 07/31/2019

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 53 YR
• Patient Weight: 61