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 MORRISTOWN MEDICAL CENTER. THE TITLE OF THIS REPORT IS ¿SYNTHETIC CARTILAGE IMPLANT HEMIARTHROPLASTY VERSUS CHEILECTOMY FOR THE TREATMENT OF HALLUX RIGIDUS¿, PUBLISHED IN 2022, WHICH IS ASSOCIATED WITH THE STRYKER CARTIVA SYSTEM. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1007/S00590-022-03469-8. THIS REPORT INCLUDES ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 52 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 TWO OF THE PATIENTS IN THE CARTIVA SCI GROUP COMPLAINED OF MILD PAIN AT THE LAST FOLLOW UP. THERE WERE NO OTHER SIGNIFICANT COMPLICATIONS OR REOPERATIONS REPORTED IN ANY OF THE PATIENTS AT THE TIME OF LATEST FOLLOW UP.