Tornier HRS ARS741703Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00846832092727), received between Aug 22, 2024 and Jun 8, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2026Detachment of Device or Device Component

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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) 2026 A PATIENT REQUIRED REVISION SURGERY DUE TO COMPONENT DISSOCIATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Insufficient Information

  MAUDE report 25426224 ↗
• InjuryDec 1, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 IN 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 23687139 ↗
• InjuryOct 15, 2025Device Dislodged or Dislocated; Osseointegration Problem; Migration; Device Dislodged or Dislocated; Osseointegration Problem; Migration

  IT WAS REPORTED THAT EIGHT-MONTH POSTOPERATIVE IMAGING REVEALED GAPPING AT THE SURGICAL SITE. THE INITIAL ACCOUNT INDICATED THAT ONLY MODULAR COMPONENTS¿INCLUDING THE POLYETHYLENE INSERT, TRAY, LOCKING CAP, AND ASSEMBLY SCREW¿WERE EXCHANGED UNDER FLUOROSCOPIC GUIDANCE. HOWEVER, THIS WAS LATER CORRECTED TO REFLECT THAT THE ENTIRE HUMERAL CONSTRUCT WAS REMOVED AND REPLACED WITH A 230 MM CONSTRUCT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23300964 ↗
• InjuryMay 26, 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 ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 22083352 ↗
• InjuryApr 28, 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 WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2013 ¿ (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2023, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 21919388 ↗
• InjuryMar 10, 2025Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT REVISION OF HIS RIGHT SHOULDER ON (B)(6) 2024, WITH TORNIER AEQUALIS IMPLANTS AND WAS REVISED ON (B)(6) 2024, DUE TO ALLEGED CONTINUED PAIN, SENSE OF CATCHING AND SLIGHT EVIDENCE OF MOTION OF THE TUBEROSITY FRACTURES. PATIENT WAS 3 WEEKS POST OP FROM A REVERSE SHOULDER ARTHROPLASTY. PATIENT HAD 2 FALLS POST-OP, ONE IN THE HOSPITAL AND WHEN AT HOME. PATIENT COMPLAINED OF CONTINUED PAIN AND A SENSE OF CATCHING IN THE SHOULDER AND THERE WAS SLIGHT EVIDENCE OF MOTION OF THE TUBEROSITY FRACTURE. ADDITIONALLY WITH ONE OF THE FALLS THE PATIENTS WOUND RE-OPENED AND HE WAS HAVING SOME DRAINAGE. DURING THE REVISION IT WAS NOTED THAT THE LOCKING SCREW FROM THE BODY TO THE DISTAL PORTION OF THE STEM HAD LOOSENED AND THE DISTAL PART OF THE STEM WAS WELL FIXED, THE BODY WAS FREELY MOVING. THE LOCKING CAP OVER THE SCREW WAS COMPLETELY INTACT BUT THE SCREW DEEP TO IT HAD LOOSENED. ALL OF THE IMPLANTS WERE REMOVED AND REPLACED.

  Patient problems: Discomfort; Fall; Pain; Wound Dehiscence

  MAUDE report 21561313 ↗
• InjuryOct 8, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF "GRINDING" WITH MOVEMENT DURING POST-OPERATIVE VISITS. A FALL RESULTED IN A FRACTURE OF THE GREATER TUBEROSITY, REQUIRING SURGICAL INTERVENTION. DURING FRACTURE FIXATION, IT WAS OBSERVED THAT THE PROXIMAL BODY HAD LOOSENED FROM THE STEM. FURTHER INSPECTION REVEALED THAT WHILE THE LOCKING CAP WAS FULLY SEATED, THE SCREW HAD LOOSENED FROM THE DISTAL STEM.

  Patient problems: Fall; Inadequate Osseointegration; Osteolysis

  MAUDE report 20400378 ↗
• InjuryAug 22, 2024Off-Label Use; Off-Label Use

  SURGEON RECENTLY USED THE REVIVE STEM WITH A PYROCARBON HUMERAL HEAD FOR A PATIENT WHO NEEDED TO BE REVISED TO A HEMIARTHROPLASTY. THIS IS OFF-LABEL USAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20023840 ↗