Simpliciti™ 7122869Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846832004836), received between May 20, 2025 and May 20, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Unstable” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryMay 20, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT LEFT PRIMARY ANATOMIC SHOULDER REPLACEMENT FOR PRIMARY IMPLANTS. OVER RECENT MONTHS PATIENT HAS BEEN COMPLAINING OF INCREASING PAIN AND INSTABILITY IN THIS SHOULDER JOINT, SUSPECTED ROTATOR CUFF FAILURE. DECISION MADE INTRA-OPERATIVELY TO REMOVE ALL PRIMARY IMPLANTS, AND CONVERT THIS PROSTHETIC JOINT TO A REVERSE SHOULDER REPLACEMENT. BOTH THE TORNIER SIMPLICITI HUMERAL COMPONENTS, AND THE PERFORM PEGGED GLENOID COMPONENT. NEGLIGIBLE BONE WAS LOST DURING THIS PART OF THE SURGERY. THE REVISION COMPONENTS IMPLANTED WERE FROM COMPETITOR (ENOVIS / DJO).

  Patient problems: Joint Laxity; Pain

  MAUDE report 22055973 ↗