Tornier Simpliciti® Shoulder System 7122876Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00846832090495), received between Apr 14, 2023 and Aug 28, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE REVISION SURGERY WAS PERFORMED IN WHICH ANATOMIC SHOULDER WAS REVISED TO REVERSE DUE TO SUBSCAPULARIS REPAIR FAILING. NO IMPLANT FAILURE WAS NOTED.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 22913092 ↗
• InjuryJan 2, 2025Unstable; Unstable

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED UNTIL (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION.

  Patient problems: Joint Laxity

  MAUDE report 21055890 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 20264656 ↗
• InjuryJul 13, 2023Naturally Worn; Naturally Worn

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2021, A PATIENT REQUIRED REVISION SURGERY DUE TO CUFF INSUFFICIENCY / GLENOID IMPLANT WEAR, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE : SINGLE STAGE REVISION.

  Patient problems: Insufficient Information

  MAUDE report 17317627 ↗
• InjuryApr 14, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THERE WAS A PATIENT UNDERWENT A TOTAL SHOULDER REPLACEMENT. DUE TO INCREASING INSTABILITY IN JOINT OVER RECENT MONTHS, SURGEON DECIDED TO CONVERT THE TSA TO A REVERSE SHOULDER REPLACEMENT. ALL COMPONENTS WERE WELL FIXED. THE GLENOID POLY IMPLANT HAD TO BE BROKEN UP IN-SITU AND REMOVED IN PIECES. THE HUMERAL COMPONENT WAS EXTREMELY WELL FIXED. SIGNIFICANT BONE WAS ATTACHED TO THE CENTRAL CORE/FINS OF THE COMPONENT. A REVERSE ARTHROPLASTY PROSTHESIS WAS IMPLANTED. STABILE RANGE OF MOTION WAS DEMONSTRATED AT THE CONCLUSION OF SURGERY.

  Patient problems: Joint Laxity

  MAUDE report 16743225 ↗