EVOLVE STEM 7.5MM +4

Additional Manufacturer Narrative

THE REPORTED EVENT THAT ONE PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE NATIONAL JOINT REGISTRY. 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. PLEASE NOTE, THAT REPORTS RECEIVED FROM THE NATIONAL JOINT REGISTRY ARE NOT PUBLISHED REPORTS AND THEREFORE WEB LINK IS NOT AVAILABLE.

Description of Event or Problem

THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER ELBOW SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN JUNE 2018 ¿ JULY 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2020 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY/OTHER, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.