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 SAINT BERNARDS HOSPITAL. THE TITLE OF THIS REPORT IS ¿DESCRIPTION OF A REVISION TECHNIQUE FOR FAILED POLYVINYL ALCOHOL HYDROGEL IMPLANT IN PATIENT WITH FREIBERG'S DISEASE ¿, PUBLISHED IN 2022, WHICH IS ASSOCIATED WITH THE STRYKER CARTIVA SYSTEM. THE ARTICLE CAN BE FOUND AT 10.1053/J.JFAS.2021.07.013. THIS REPORT INCLUDES ANALYSIS OF THE CLINICAL DATA OF ONE CASE REPORT. 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 A 35 YO MALE TREATED WITH CARTIVA IMPLANT ON 4TH MTP FOR FREIBERG DISEASE. "FINDINGS: THERE WAS A BONE TO BONE DORSAL IMPINGEMENT OF THE JOINT. THE PVA IMPLANT WAS FRAGMENTED AND NON-FUNCTIONING PRODUCING A LOOSE BODY WITHIN THE JOINT." REVISED WITH A BONE GRAFT.