UNKNOWN CARTIVA IMPLANT

Description of Event or Problem

THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE GATESHEAD HEALTH FOUNDATION NHS TRUST. THE TITLE OF THIS REPORT IS ¿MIDTERM FUNCTIONAL OUTCOMES OF SYNTHETIC CARTILAGE IMPLANT (SCI) ARTHROPLASTY FOR HALLUX RIGIDUS¿, PUBLISHED ON [DATE], WHICH IS ASSOCIATED WITH THE STRYKER CARTIVA SYSTEM. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1053/J.JFAS.2024.09.006. THIS REPORT INCLUDES ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 70 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 THREE OUT OF 70 PATIENTS (4.3%) HAD REVISION TO FIRST MTP FUSION DUE TO ONGOING PAIN. ALL OF THEM HAD SUCCESSFUL UNION AND RESOLUTION OF THEIR SYMPTOMS." "THREE PATIENTS WHO NEEDED REVISION TO FUSION WAS DUE TO PERSISTENT PAIN RELATED TO THE SUBSIDENCE OF THE IMPLANT" 5 YEAR FOLLOW-UP." THIS IS PATIENT #3 OUT OF 3.

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.