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

Catalog Number UNK_WCA

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

Patient Problem Insufficient Information (4580)

Event Date 05/20/2022

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.Device remains implanted in patient.

Event Description

The manufacturer became aware of a patient comment on a foot health forum for information and discussion on foot problems.The post can be found at: http://foot-health-forum.Com/index.Php?threads/failed-cartiva.126530/.In the comment the reporter alleged: "i also just found out that my cartiva implant has failed and i need to get a fusion.I just had the surgery for the cartiva implant 7 months ago and am so upset that this has already happened.Seeing all of the coverage online about the negative results makes me wonder why my doctor used the cartiva implant at all.I wish i had done my own research prior to my surgery, but i trusted her.".

• Brand Name: UNKNOWN CARTIVA IMPLANT
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16404352
• MDR Text Key: 309891460
• Report Number: 3009351194-2023-00004
• 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: 02/20/2023

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
• Device Catalogue Number: UNK_WCA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/20/2023
• 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): Other