Tornier HRS ARS655103Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832093274), received between Jun 25, 2024 and Jul 15, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2025Loss of Osseointegration; Biocompatibility; Device Dislodged or Dislocated; Loss of Osseointegration; Biocompatibility; Device Dislodged or Dislocated

  A REVISION SURGERY WAS REQUIRED FOLLOWING THE DISENGAGEMENT OF THE TRAY FROM THE REVIVE STEM IN AN ACTIVE, INDEPENDENTLY MOBILE PATIENT WHO PRESENTED WITH ACUTE SHOULDER PAIN. INTRAOPERATIVE FINDINGS REVEALED A LOOSE STEM, FAILURE AT THE MORSE TAPER INTERFACE, PSEUDOMEMBRANE FORMATION AROUND THE TRAY, AND SIGNIFICANT METALLOSIS. THE STEM, TRAY, AND LINER WERE REVISED USING A LARGER STEM SIZE, WHILE THE GLENOSPHERE AND SCREWS REMAINED INTACT DUE TO STABLE FIXATION. POSTOPERATIVELY, THE PATIENT UNDERWENT STANDARD REHABILITATION, INCLUDING SLING IMMOBILIZATION FOR 3 TO 4 WEEKS FOLLOWED BY GENTLE MOBILIZATION UNDER PHYSIOTHERAPY SUPERVISION. X-RAY IMAGES ARE NOT INCLUDED DUE TO PATIENT CONFIDENTIALITY.

  Patient problems: Inadequate Osseointegration; Metal Related Pathology; Pain

  MAUDE report 22512417 ↗
• InjuryJun 25, 2024Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "IT WAS REPORTED THAT A LOOSENING OF THE COMPONENTS WAS DETECTED, AND IT WAS WEARING A LOCKING CAP THAT IS SUPPOSED TO LOCK THE COMPONENTS. AFTER APPROXIMATELY 8 MONTHS OF INITIAL SURGERY, THE PATIENT NOTICED A ¿CLICK¿ AND THEY WENT TO THE EMERGENCY ROOM, WHERE THEY UNDERWENT AN X-RAY SHOWING THE DISASSEMBLY OF THE IMPLANT. HOWEVER, IT WAS NOT UNTIL (B)(6) 2024 THAT THEY WERE SEEN BY A TRAUMATOLOGIST WHO KNEW ABOUT THE IMPLANT AND WAS THE ONE WHO DETECTED THAT THE CONDITION OF THE STEM WAS NOT WHERE IT SHOULD BE. THE INITIAL SURGERY WAS ON (B)(6) 2023 AND A TORQUE SCREWDRIVER WAS USED TO ENSURE THAT THE TIGHTENING TORQUE WAS DONE WITH THE NECESSARY FORCE. THE INITIAL SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANYTHING TO REPORT."

  Patient problems: Inadequate Osseointegration; Nonunion/Delayed-union Bone Fracture

  MAUDE report 19610603 ↗