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 HOSPITAL FOR SPECIAL SURGERY - NEW YORK. THE TITLE OF THIS REPORT IS ¿A COMPARISON OF PROMIS SCORES OF METATARSOPHALANGEAL JOINT ARTHRODESIS AND POLYVINYL ALCOHOL HYDROGEL IMPLANT HEMIARTHROPLASTY FOR HALLUX RIGIDUS¿, PUBLISHED IN 2021, WHICH IS ASSOCIATED WITH THE STRYKER CARTIVA SYSTEM. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1177/2473011424S00043. THIS REPORT INCLUDES ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 82 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 "SIX PATIENTS (7.3%) IN THE SCI GROUP UNDERWENT REVISION TO MTP JOINT ARTHRODESIS WITHIN 3 YEARS DUE TO CONTINUED PAIN AND/OR SUBSIDENCE OF THE IMPLANT." THIS IS PATIENT #2 OUT OF 6.