UNKNOWN CARTIVA IMPLANT

Description of Event or Problem

THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE. THE TITLE OF THIS REPORT IS ¿MANAGEMENT OF PERIPROSTHETIC POLYVINYL ALCOHOL SYNTHETIC CARTILAGE IMPLANT INFECTION WITH STAGED FIRST METATARSOPHALANGEAL JOINT ARTHRODESIS ¿, PUBLISHED IN 2022, WHICH IS ASSOCIATED WITH THE STRYKER CARTIVA SYSTEM. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.7547/20-105. THIS REPORT INCLUDES ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 1 PATIENT. 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 ONE PATIENT DEVELOPED INTERMITTENT PAIN AND SWELLING. THE IMPLANT HAD SUBSIDED WITHIN THE FIRST METATARSAL HEAD. THE IMPLANT WAS EXPLANTED."

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.