TORNIER SIMPLICITI NUCLEUS SIZE 1

Additional Manufacturer Narrative

THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE (DWG401) IS COMMERCIALLY AVAILABLE AND CLEARED UNDER 510K # K143552. THE REPORTED EVENT THAT ONE PATIENT REQUIRED REVISION SURGERY DUE TO IMPINGEMENT AND SUNKEN IMPLANT(AVN) 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THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024, A PATIENT REQUIRED REVISION SURGERY DUE TO IMPINGEMENT AND SUNKEN IMPLANT(AVN), WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.