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

Device Problem Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 11/19/2019

Event Type  Injury  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

It was reported by the patient in medwatch mw5093802 that, "i had cartiva synthetic implant (csi) surgery on my right big toe for hallux rigidus.The surgery was done by dr (b)(6)), at center for surgery encinitas 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 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 SCI
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta, ga
• Manufacturer (Section G): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta, ga
• Manufacturer Contact: matthew parrish ; 1023 cherry rd; memphis, tn
• MDR Report Key: 10032594
• MDR Text Key: 194493007
• Report Number: 1043534-2020-00092
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 04/10/2020

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2020
• Initial Date FDA Received: 05/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR