UNKNOWN CARTIVA IMPLANT

Description of Event or Problem

THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE BAYLOR UNIVERSITY MEDICAL CENTER. THE TITLE OF THIS REPORT IS ¿3D-PRINTED HALLUX AND LESSER METATARSOPHALANGEAL JOINT REPLACEMENT¿, PUBLISHED IN 2022, WHICH IS ASSOCIATED WITH THE STRYKER CARTIVA SYSTEM. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1016/B978-0-323-82565-8.00029-9. 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 SHOWING A 2ND MTPJ INSTABILITY APPEARANCE THAT SHOW DORSAL SUBLUXATION/DISLOCATION OF THE PROXIMAL PHALANX RELATIVE TO THE METATARSAL HEAD IN THE SAGITTAL PLANE WITH PLANTAR PLATE TEAR OR EXTENSOR/FLEXOR TENDON IMBALANCE, OR COLLATERAL LIGAMENT INJURY IN THE CORONAL PLANE.

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.