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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 10/20/2017

Event Type  Injury  

Event Description

Received a cartiva implant in the metatarsophalangeal joint for treatment of hallux rigidus.Pain in creased after surgery.After 4 weeks the device recessed back in to the metatarsal bone and flattened so that there was no longer a space in the joint.

• Brand Name: CARTIVA SCI
• Type of Device: PROSTHESIS METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): CARTIVA, INC.
• MDR Report Key: 7914481
• MDR Text Key: 122168122
• Report Number: MW5080169
• Device Sequence Number: 1
• Product Code: LZJ
• 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: 09/25/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 54 YR
• Patient Weight: 84