Tornier HRS ARS655102Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00846832093267), received between Jun 26, 2023 and Apr 15, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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 16, 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.

• InjuryApr 15, 2026Fracture

  A REVISION SURGERY HAS BEEN PERFORMED DUE TO A BROKEN SCREW ON THE REVIVE STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888393 ↗
• InjuryApr 21, 2025Biocompatibility; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Biocompatibility; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  ORIGINAL PROCEDURE TOOK PLACE IN 2024. PROCEDURE WAS A REVISION OF ANOTHER COMPANIES ANATOMIC SHOULDER REPLACEMENT. REVISION ON A POLY SWAP AND GLENOSPHERE EXCHANGE. X-RAYS IN THEATRE SHOW FLEX REVIVE SCREW AND CAP HAVE BACKED OUT OF PROSTHESIS MAKING THE CONSTRUCT LOOSE. PATIENT SHOWED CLEAR SIGNS OF METALOSIS AND QUERY INFECTION. ALL IMPLANTS EXTRACTED AND CEMENT SPACER IMPLANTED.

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 21878040 ↗
• InjuryMar 10, 2025Device Dislodged or Dislocated; Osseointegration Problem; Migration; Device Dislodged or Dislocated; Osseointegration Problem; 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; Inadequate Osseointegration; Pain; Wound Dehiscence

  MAUDE report 21561455 ↗
• InjuryFeb 4, 2025Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "REVIVE HUMERAL STEM APPEARS TO BE SEPARATING. THE LOCKING CAP AND THE ASSEMBLY SCREWS SEEM TO BE BACKING OUT CAUSING THE PROXIMAL BODY, THE SPACER AND THE DISTAL STEM TO BE MIGRATING AWAY FROM EACH OTHER."

  Patient problems: Inadequate Osseointegration

  MAUDE report 21307314 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO DISCOMFORT.

  Patient problems: Discomfort

  MAUDE report 20508303 ↗
• 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 20400004 ↗
• InjuryApr 22, 2024Osseointegration Problem; Osseointegration Problem

  REMOVAL OF FLEX REVIVE STEM AND WIRES AND REPLACEMENT WITH CEMENT SPACER DUE TO DISTAL HUMERAL (LIKELY) INFECTION AND PROSTHETIC LOOSENING. THE PATIENT HAS RA AND A BONE DENSITY DEFICIENCY. THE REVIVE STEM WAS USED TO STABILIZE THE DISPLACED DISTAL HUMERUS AND CABLES USED TO SECURE THE BONE. THERE WAS EVIDENCE OF LOOSENING OF THE DISTAL HUMERUS ONLY AND NO EVIDENCE ON XR OF ANY SHOULDER JOINT ISSUE.

  Patient problems: Inadequate Osseointegration; Rheumatoid Arthritis; Unspecified Infection

  MAUDE report 19160110 ↗
• InjuryJun 26, 2023Device Dislodged or Dislocated; Osseointegration Problem; Migration; Device Dislodged or Dislocated; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE OF STEM, METAPHYSIS AND INSERT DUE TO HUMERAL REVIVE PROSTHESIS DISSOCIATION AND POSSIBLE SCREW LOOSENING. GLENOID BASEPLATE AND GLENOSPHERE WERE RETAINED FROM PRIOR PROCEDURE. ASSESSED AS DEFINITELY RELATED TO THE STUDY DEVICE, AND POSSIBLY RELATED TO THE SURGICAL PROCEDURE BY THE INVESTIGATOR.

  Patient problems: Joint Dislocation; Osteolysis

  MAUDE report 17200179 ↗