Tornier Simpliciti® Shoulder System 7122872Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00846832090457), received between Jan 9, 2023 and Mar 10, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 (B)(6) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO NATIVE GLENOID SURFACE EROSION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Erosion

  MAUDE report 24560655 ↗
• InjuryMar 3, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2019 A PATIENT REQUIRED REVISION SURGERY DUE TO STIFFNESS & UNEXPLAINED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 24494100 ↗
• InjuryJun 10, 2025Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO UNEXPLAINED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Implant Pain

  MAUDE report 22178997 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT (B)(6) SHOUT - TORNIER SHOULDER OUTCOMES STUDY PATIENT REPORTED PAIN IN THE SHOULDER AFTER POWER WASHING".

  Patient problems: Implant Pain

  MAUDE report 21122536 ↗
• InjurySep 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SUBJECT (B)(6) SHOUT - TORNIER SHOULDER OUTCOMES STUDY. INFECTION PAIN AND GLENOID LOOSENING. ROTATOR CUFF INSUFFICIENCY AND INFECTION. RE-OPERATION ON (B)(6) 2021; IMPLANTS REMOVED AND PLACEMENT OF ANTIBIOTIC SPACER, RE-OPERATION ON (B)(6) 2021; REMOVAL OF SPACER, RE-IMPLANTATION OF REVERSE TOTAL SHOULDER.

  Patient problems: Bacterial Infection; Implant Pain; Inadequate Osseointegration

  MAUDE report 20244133 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A REVISION SURGERY DUE TO AN INFECTION CAUSED BY P. ACNES, AS IDENTIFIED BY THE BACTERIAL CULTURE. NO OTHER CONTRIBUTING FACTORS WERE REPORTED, AND THE IMPLANTS WERE DISCARDED AFTER THE PROCEDURE.

  Patient problems: Bacterial Infection

  MAUDE report 20092156 ↗
• InjuryOct 10, 2023Adverse 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) 2019 A PATIENT REQUIRED REVISION SURGERY DUE UNEXPLAINED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION.

  Patient problems: Implant Pain

  MAUDE report 17909355 ↗
• 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) 2022 A PATIENT REQUIRED REVISION SURGERY DUE TO GLENOID IMPLANT WEAR, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE : SINGLE STAGE REVISION.

  Patient problems: Insufficient Information

  MAUDE report 17317621 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL SHOULDER REPLACEMENT. DURING SURGERY, SURGEON NOTED THAT A TENDONOUS TEAR OF THE JUNCTION OF THE SUPRASPINATUS AND SUBSCAPULARIS TENDONS EXISTED. SURGEON PERFORMED A REPAIR USING ANCHORS. POST-OP REHABILITATION PROCEEDED WITHOUT INCIDENT. HOWEVER, SEVERAL MONTHS FOLLOWING PRIMARY SURGERY, PATIENT COMPLAINED OF INCREASING PAIN, SWELLING AND INSTABILITY OF SHOULDER JOINT. SURGEON PERFORMED A SHOULDER ARTHROSCOPY, TO DISCOVER FULL THICKNESS TEARS OF BOTH OF THE AFORE MENTIONED TENDONS. DISCUSSED WITH THE PATIENT, WHERE A DECISION WAS MADE TO CONVERT THE SURGERY TO A REVERSE SHOULDER REPLACEMENT. DURING SURGERY TODAY, BOTH HUMERAL AND GLENOID COMPONENTS WERE REMOVED, AS PER THE RECOMMENDED SURGICAL TECHNIQUE. THE SURGEON HAS NO EXPLANATION AS TO WHY THE PATIENT'S ROTATOR CUFF TENDONS DETERIORATED IN SUCH A SHORT PERIOD OF TIME, RENDERING THE PROSTHETIC JOINT UNSTABLE, OTHER THAN HIS BELIEF THAT MICROSCOPIC POLY DEBRIS MAY HAVE SET UP AN INFLAMMATORY LOCAL RESPONSE THAT INHIBITED THE TENDON TEAR TO HEAL. ALL COMPONENTS DISCARDED.

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 16124022 ↗