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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.On (b)(6) 2020 stryker trauma and extremities acquired cartiva, wright medical, tornier inc.And tornier sas.An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr/vigilance process.

Event Description

I have a failed cartiva implant and am now currently looking for other options.I am trying to figure out why it failed, and i am still in more pain than before.I had my surgery on (b)(6) 2017.Information received from a patient thru cartiva website.

• Brand Name: CARTIVA SCI IMPLANT FOR MTP
• Type of Device: METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PROSTHESIS,
• Manufacturer (Section D): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta GA 30005
• Manufacturer (Section G): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta GA 30005
• Manufacturer Contact: matthew parrish ; 1023 cherry rd; memphis, TN 38117
• MDR Report Key: 13606580
• MDR Text Key: 294666581
• Report Number: 3009351194-2022-00085
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2018

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 02/25/2022
• 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): Disability
• Patient Sex: Female