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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 02/13/2018

Event Type  Injury  

Event Description

I had cartiva synthetic implant (csi) surgery on my right big toe for hallux rigidus.The surgery was done by dr (b)(6) of (b)(6), at (b)(6) outpatient surgery center.The surgeon was a failed csi surgery and after 1 1/2 years more of bad pain.I had corrective surgery on (b)(6) 2020 (removal of implant, bone grafts and fusion of big toe) by dr (b)(6) of (b)(6).I had to remain in hosp for 2 nights after the corrective surgery due to complications unrelated to the surgery.I suffered vocal cord abrasion due to anesthesiologist insertion of air tube.I want to report the failed cartiva implant surgery so the fda is properly notified as i do not know if dr (b)(6) reported it as failed.The implant had completely receded into the hole as the implant hole was to deep.When i first read the fda studies on csi it showed a very low (single digit) failure rate but in the real world that failure rate is well over (b)(4)%, why?; dr (b)(6), (b)(6); cat/lot/ serial number/ udi: ask dr (b)(6).Fda safety report id# (b)(4).

• Brand Name: CARTIVA SYNTHETIC IMPLANT
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): WRIGHT MEDICAL GROUP / CARTIVA, INC.
• MDR Report Key: 9847735
• MDR Text Key: 184179156
• Report Number: MW5093802
• 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: 03/14/2020
• 2 Devices were Involved in the Event: 1 2

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: 03/17/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 69 YR
• Patient Weight: 68