UNKNOWN TORNIER AEQUALIS REVERSED II
Received Jul 2, 2026 · Event occurred Oct 9, 2025
Report 3000931034-2026-00541 · MDR key 25690356
Device
Generic name
Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Manufacturer
Tornier S.a.s.Catalog number
UNK_WTM
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Joint Impingement
Narrative
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: 12 PATIENTS WITH GRADE 1 AND 2 SCAPULAR NOTCHING THIS IS PATIENT 10 OUT OF 12.