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 Failure of Implant (1924)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device disposition is unknown.

Event Description

This event is being reported due to the following social media post: i don't even know the name, it was a cartiva implant in 2019 that failed and was slowly destroying the surrounding bone - it looked spongy in the xray, like a pumice stone, not solid.So they had to dig that out, replace the gap with a cadaver bone and now there's two screws holding it together, and in spring if the screws are bothering me the doctor said she can remove those in an office visit.I don't know of too many surgeries that are 100% effective.I had revision surgery because we used a newish technology (cartiva implant) which has since been pulled off the market, and mine failed.And also, you could in theory have successful surgery, but go back to the same behaviors that caused the bunion in the first place( if it wasn't genetic): the high heels, and all.If you do things to your feet that they aren't designed to do, they'll have points of failure.In that way it's like having a lung transplant, refusing to quit smoking, and attributing a second round of lung cancer to the surgery failing.

Manufacturer Narrative

The reported event was not confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

This event is being reported due to the following social media post: i don't even know the name, it was a cartiva implant in 2019 that failed and was slowly destroying the surrounding bone - it looked spongy in the xray, like a pumice stone, not solid.So they had to dig that out, replace the gap with a cadaver bone and now there's two screws holding it together, and in spring if the screws are bothering me the doctor said she can remove those in an office visit.I don't know of too many surgeries that are 100% effective.I had revision surgery because we used a newish technology (cartiva implant) which has since been pulled off the market, and mine failed.And also, you could in theory have successful surgery, but go back to the same behaviors that caused the bunion in the first place( if it wasn't genetic)-- the high heels, and all.If you do things to your feet that they aren't designed to do, they'll have points of failure.In that way it's like having a lung transplant, refusing to quit smoking, and attributing a second round of lung cancer to the surgery failing.

• 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: 17056205
• MDR Text Key: 316464696
• Report Number: 3009351194-2023-00014
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 08/03/2023
• Supplement Dates FDA Received: 08/30/2023
• 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): Required Intervention