UNKNOWN CARTIVA IMPLANT

Additional Manufacturer Narrative

THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING THE POST-MARKET SURVEILLANCE LITERATURE REVIEW. THE ALLEGED EVENT COULD NOT BE CONFIRMED, SINCE NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR OR THE ARTICLE. MORE DETAILED INFORMATION ABOUT THE PATIENT MEDICAL HISTORY, THE EVENT CIRCUMSTANCES, AND MEDICAL REPORTS MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.

Description of Event or Problem

THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE DEPARTMENT OF ORTHOPAEDICS, DUKE UNIVERSITY HOSPITAL. THE TITLE OF THIS REPORT IS ¿REVISION SURGERY AFTER FAILED INDEX SYNTHETIC CARTILAGE IMPLANT RESURFACING FOR HALLUX RIGIDUS: SINGLE-SURGEON 5-YEAR EXPERIENCE ¿, PUBLISHED IN 2024, WHICH IS ASSOCIATED WITH THE STRYKER CARTIVA SYSTEM. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1177/19386400221147773 THIS REPORT INCLUDES ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 219 PATIENTS. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND AT THIS TIME NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE. IT WAS REPORTED THAT 18 PATIENTS DEVELOPED SCI SUBSIDENCE WITH REQUIRED REVISION. THIS IS PATIENT 16 OF 18.