MAUDE Adverse Event Report: CARTIVA, INC UNKNOWN_WRIGHT CARTIVA-ALPHARETTA_PRODUCT; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT

Catalog Number UNK_WCA

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

Patient Problems Nerve Damage (1979); Loss of Range of Motion (2032); Discomfort (2330); Irritability (2421); Implant Pain (4561)

Event Date 12/30/2020

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.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient had a cartiva sci implanted in her right great toe.It is further alleged that the patient experienced loss of mobility, nerve damage and debilitating pain, along with constant irritation and discomfort in the location of the device and was revised 25 months after the initial surgery.

Manufacturer Narrative

Correction: d4 catalog #.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient had a cartiva sci implanted in her right great toe.It is further alleged that the patient experienced loss of mobility, nerve damage and debilitating pain, along with constant irritation and discomfort in the location of the device and was revised 25 months after the initial surgery.

• Brand Name: UNKNOWN_WRIGHT CARTIVA-ALPHARETTA_PRODUCT
• 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: 15868860
• MDR Text Key: 304345068
• Report Number: 3009351194-2022-00111
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

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?: Yes
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/28/2022
• Supplement Dates Manufacturer Received: 08/04/2023
• Supplement Dates FDA Received: 08/04/2023
• 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
• Patient Sex: Female