CARTIVA IMPLANT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-22 for CARTIVA IMPLANT manufactured by Wright Medical / Cartiva Inc..

Event Text Entries

[146210824] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5086849
• MDR Report Key: 8636324
• Date Received: 2019-05-22
• Date of Report: 2019-05-20
• Date of Event: 2018-12-28
• Date Added to Maude: 2019-05-23
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: CARTIVA IMPLANT
• Generic Name: PROSTHESIS METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Product Code: PNW
• Date Received: 2019-05-22
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: WRIGHT MEDICAL / CARTIVA INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention; 3. Deathisabilit	2019-05-22