Tornier HRS ARS741702Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00846832092710), received between May 12, 2023 and Sep 18, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Unstable” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Failure to Osseointegrate

  The manufacturer received a report from the National Joint Registry that contains unpublished collected data on the usage and the outcomes of the shoulder joint replacement.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 ASEPTIC LOOSENING HUMERUS, DISLOCATION/SUBLUXATION , which was not previously reported to the manufacturer.

  Patient problems: Osteolysis

  MAUDE report 50815719 ↗
• InjuryJun 5, 2026Device Dislodged or Dislocated

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 BETWEEN 2024-2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2026 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE/DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s); Subluxation

  MAUDE report 25404438 ↗
• InjuryMay 15, 2026Unstable

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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

  Patient problems: Joint Laxity

  MAUDE report 25180912 ↗
• InjuryMar 10, 2026Unstable

  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 FEB. 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 24556761 ↗
• InjuryFeb 23, 2026Unstable

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN MARCH 2023 - SEPTEMBER 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.

  Patient problems: Joint Laxity

  MAUDE report 24413941 ↗
• InjurySep 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Subluxation

  MAUDE report 22993224 ↗
• InjuryAug 13, 2025Loss of Osseointegration; Loss of Osseointegration

  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 JULY 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING HUMERUS AND DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis; Subluxation

  MAUDE report 22794911 ↗
• InjuryMar 13, 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) 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 21594245 ↗
• InjuryJun 27, 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 MAY 31, 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 19629221 ↗
• 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 19160023 ↗
• InjuryOct 9, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED IN A LAWSUIT THAT THE PATIENT REPORTED HAVING REFRACTORY PAIN AND DYSFUNCTION OF THE SHOULDER WHICH WAS REFRACTORY TO CONSERVATIVE MEASURES. PREOPERATIVE IMAGING WAS SUGGESTIVE OF LOOSENING OF THE HUMERAL COMPONENT, SPECIFICALLY AT THE JUNCTION OF THE PROXIMAL HUMERAL BODY TO THE HUMERAL STEM AT THE ASSEMBLY SCREW JUNCTION.

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 17901586 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED WITH INFECTION. THE PATIENT WAS REVISED AND IMPLANTED WITH CEMENT ANTIBIOTIC SPACER.

  Patient problems: Bacterial Infection

  MAUDE report 16924437 ↗