AEQUALIS REVERSED FRACTURE STEM D. 11MM - L. 130MM - HAP EU
Received Jun 16, 2026 · Event occurred Feb 25, 2026
Report 3000931034-2026-00504 · MDR key 25515979
Device
Generic name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Manufacturer
Tornier S.a.s.Catalog number
DWD913
Lot number
6358AX
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
75 YR · Male
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
THIS CATALOG (DWD913) IS NOT COMMERCIALLY AVAILABLE IN US BUT A SIMILAR DEVICE DWD903 IS CLEARED UNDER 510K (K131231). THE REPORTED EVENT 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THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2026 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.