Tornier Simpliciti® Shoulder System 7122873Recalls & reported problems

Tornier, Inc. · Class 2 · Implant

All models of Tornier Simpliciti Shoulder System (8)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846832090464), received between May 12, 2026 and May 12, 2026 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Discomfort1
Muscle/Tendon Damage1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, THE PATIENT UNDERWENT A RIGHT PRIMARY ANATOMIC SHOULDER REPLACEMENT ON (B)(6) 2024. ADVISED BY SURGEON YESTERDAY THAT THE PATIENT NOW REQUIRES A REVISION (REMOVAL OF ALL IMPLANTS), AND CONVERSION TO A REVERSE SHOULDER REPLACEMENT, AS THE PATIENT'S ROTATOR CUFF HAS FAILED. THE SURGERY WAS SCHEDULED FOR (B)(6) 2026. RIGHT PRIMARY SHOULDER ARTHROPLASTY ON 6.8.24. PATIENT HAD BEEN COMPLAINING OF DISCOMFORT IN PROSTHETIC RIGHT SHOULDER JOINT APPROX 6 MONTHS POST-OP. X-RAY AT THIS TIME SHOWED SOME EVIDENCE OF LUCENCY AROUND GLENOID COMPONENT. CT SCAN AT 12 MONTHS POST-OP SHOWED INCREASING LUCENCY, HE COMPLAINED OF MORE DISCOMFORT. CT SCAN LATE 2025 SHOWED LOOSE GLENOID COMPONENT, REVISION SURGERY BOOKED. SIMPLICITI HEAD REMOVED, SIMPLICITI NUCLEUS WAS SOLID, BUT THE REVISION TOOLS GOT IT OUT QUITE CLEAN. MINIMAL BONE LOSS. GLENOID PERFORM PLUS POLY WAS VERY LOOSE, CAVITY BEHIND IT. COMPONENT HAD MINIMAL CEMENT STILL ADHERED TO IT. MULTIPLE TISSUE SAMPLES TAKEN, THOUGH SURGEON STATED THAT THERE WERE NO CLINICAL SIGNS OF INFECTION. COPIOUS LAVAGE. SHOULDER JOINT REDUCED, STABLE THROUGH FULL RANGE OF MOTION. EXPLANTED PROSTHESIS BEING RETURNED (IN A STERI-PEEL PKT) WIT
Patient problems: Discomfort; Muscle/Tendon Damage
MAUDE report 25152861 ↗

Device details

UDI-DI	`00846832090464`
Brand	Tornier Simpliciti® Shoulder System
Model	7122873
Company	Tornier, Inc.
Product code	PKC · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
Class	Class 2
FDA submission	K143552
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 6, 2025

Device type (GMDN): Stem-fixed metallic humeral head prosthesis

An implantable artificial substitute for a diseased or injured humeral head. It is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and designed to be attached to a humeral stem prosthesis and to articulate with the natural glenoid fossa, a glenoid fossa prosthesis, or a humeral head bipolar component as part of a shoulder replacement.

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All Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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