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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); No Code Available (3191)

Event Date 12/28/2018

Event Type  Injury  

Event Description

My cartiva implant inflamed and removal of stitches was extremely painful.Dr told me i could wear any shoe i could tolerate and do anything i could tolerate on day stitches were removed.By thanksgiving my foot was draining pus.Dr put me on oral antibiotic's "as a precaution".December 21 i requested and had an mri which the dr looked at and said all he saw was "sesamoiditis" he did not make any recommendations, and did not follow up.Ok the mri report that said evidence of bone infection is present and nuclear imaging should be done.He told me via email that he was going on vacation for 2 weeks and only renewed my oral antibiotic when i requested it.Continued to insist nothing was wrong.I experienced locking of my left knee and extreme flu like symptoms that i associated with a septic arthritis.Went to gp who sent me to infectious disease dr who treated.F/u mri i requested shows cartiva has receded into the bone.There is no space where dr removed healthy cartilage.Foot went to level 5 pain with every step.Dr failed to acknowledge a failure.Cartiva continues to insist their success rate is high.It is not.Bone infection.Fda safety report id# (b)(4).

• Brand Name: CARTIVA IMPLANT
• Type of Device: PROSTHESIS METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): WRIGHT MEDICAL / CARTIVA INC.
• MDR Report Key: 8636324
• MDR Text Key: 146210824
• Report Number: MW5086849
• 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: 05/20/2019

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 59 YR
• Patient Weight: 66