UNKNOWN TORNIER AEQUALIS STEM

Additional Manufacturer Narrative

THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS IDENTIFIED DURING POST MARKET SURVEILLANCE LITERATURE. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1016/J.JSE.2025.10.010. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) 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 INSTITUT DE CHIRURGIE RÉPARATRICE. THE TITLE OF THIS REPORT IS "PATIENT-SPECIFIC BIO-RSA FOR THE TREATMENT OF GLENOID DYSPLASIA (TYPE-C) OSTEOARTHRITIS", PUBLISHED ON 9 OCTOBER 2025, WHICH IS ASSOCIATED WITH THE STRYKER TORNIER AEQUALIS REVERSED II AND TORNIER FLEX SYSTEM. THE ARTICLE CAN BE FOUND ON HTTPS://DOI.ORG/10.1016/J.JSE.2025.10.010. 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: 1 PATIENT WITH UNCEMENTED STEM HAD STEM SUBSIDENCE WITH PAIN, PROMPTING AN INFECTION WORKUP, WHICH DID NOT SHOW EVIDENCE IN FAVOR OF INFECTION. AUTHORS NOTED THAT NO REOPERATIONS OR REVISIONS OCCURED.