MAUDE Adverse Event Report: WRIGHT MEDICAL GROUP / CARTIVA INC. CARTIVA IMPLANT; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 09/11/2017

Event Type  Injury  

Event Description

On (b)(6) 2017 received a cartiva implant left great toe.It failed almost immediately.I lost the ability to move my toe, increased pain, constant anguish.A few weeks after receiving a cartiva implant, a physical therapist said my toe was fused and physical therapy wouldn't help.I now have bone on bone pain.My pain, ability to move my toe joint, my mobility and my quality of life are significantly worse after getting cartiva.I'm miserable.Based on my research, there is a discrepancy in cartiva's clinical study data (glowing, amazing reviews) and the amount of cartiva complaints after being fda approved.This product should be taken off the market.I'd like to file a formal complaint about the cartiva implant.Https://www.Cartiva.Net/home/about; more pain, less mobility.Fda safety report id# (b)(4).

• Brand Name: CARTIVA IMPLANT
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT
• Manufacturer (Section D): WRIGHT MEDICAL GROUP / CARTIVA INC.
• MDR Report Key: 8632306
• MDR Text Key: 145990122
• Report Number: MW5086828
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/19/2019

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: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 59