Simpliciti™ 7122870Recalls & reported problems
Tornier, Inc. · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832004843), received between Feb 17, 2026 and Apr 30, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Inadequacy of Device Shape and/or Size1
Patient problems
- Erosion1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2026Adverse Event Without Identified Device or Use 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THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 FEB. 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO NATIVE GLENOID SURFACE EROSION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Erosion
MAUDE report 25040056 ↗InjuryFeb 17, 2026Inadequacy of Device Shape and/or Size
A REVISION SURGERY WAS PERFORMED DUE TO NON-OPTIMAL FIT OF THE COMPONENTS WHICH PLACED STRESS ON THE ROTATOR CUFF AS WELL AS PAIN.
Patient problems: Pain
MAUDE report 24364511 ↗
Other Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained devices
- Tornier Perform DWM003ATornier, Inc. · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained1 recall1 report
- Sidus® Stem-Free Shoulder 01.04555.500Zimmer GmbH · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained1 recall1 report
- DJO SURGICAL 520-08-021Encore Medical, L.P. · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained20 reports
- INHANCE 5200-00-036Depuy (Ireland) · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained17 reports
- Easytech Anatomical Shoulder System 314-0038Fx Solutions · Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained14 reports
- Tornier Simpliciti® Shoulder System 7122872Tornier, Inc. · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained9 reports
- GLOBAL ICON 1140-20-046Depuy (Ireland) · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained6 reports
- GLOBAL ICON 1140-10-046Depuy (Ireland) · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained6 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.