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

Model Number NOT SURE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Nerve Damage (1979); Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 08/17/2016

Event Type  Injury  

Event Description

I had intra-articular fracture of first mtp joint, my physician suggested newly approved synthetic cartilage cartiva.I underwent surgery in (b)(6) 2016 but my pain became worse.My functional status progressively got worse and i have developed a limp and also a nerve pain.Fda safety report id# (b)(4).

• Brand Name: CARTIVA SYNTHETIC CARTILAGE
• Type of Device: PROSTHESIS METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): WRIGHT MEDICAL GROUP / CARTIVA, INC.
• MDR Report Key: 8865092
• MDR Text Key: 153641789
• Report Number: MW5088783
• 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: 08/02/2019

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: Health Professional
• Device Model Number: NOT SURE
• Device Catalogue Number: NOT SURE
• Device Lot Number: NOT SURE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 42 YR