Tornier HRS ARS741801Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00846832093014), received between Aug 23, 2023 and Sep 17, 2026 — classified as 14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 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  The manufacturer received a report from the National Joint Registry that contains unpublished collected data on the usage and the outcomes of the shoulder joint replacement.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 Aug 2026.During the review of the report, it was identified that on (b)(6)2026 a patient required revision surgery due to instability, which was not previously reported to the manufacturer.

  Patient problems: Joint Laxity

  MAUDE report 50803916 ↗
• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 MARCH 2025-MARCH 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 25180909 ↗
• InjuryApr 29, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 (B)(6) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 25024742 ↗
• InjuryFeb 23, 2026Fracture; 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 IN 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTUR AND ASEPTIC LOOSENING HUMERUS AND IMPLANT FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s); Osteolysis

  MAUDE report 24414123 ↗
• 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 23687209 ↗
• InjuryNov 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 REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN (B)(6) 2023 - (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 23550300 ↗
• InjurySep 22, 2025Osseointegration Problem; Osseointegration Problem

  THE DISENGAGEMENT OF ASSEMBLY SCREW WITHIN PROXIMAL AND DISTAL BODY CAUSING THE PROXIMAL PART OF REVIVE STEM TO BECOME UNSTABLE RESULTING IN REVISION SURGERY WAS REPORTED. ALSO, POROUS COATING OF PROXIMAL PART OF STEM HAS ERODED/COME OFF THE STEMS SURFACE. PATIENT HAD SYMPTOMS AND HEARD AN AUDIBLE CLUNK, X RAY OF STEM CONFIRMED ISSUE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23111639 ↗
• InjurySep 8, 2025Detachment of Device or Device Component; Detachment 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) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE AND COMPONENT DISSOCIATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s)

  MAUDE report 22993006 ↗
• 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 LYSIS OF HUMERUS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis

  MAUDE report 22084117 ↗
• InjuryMar 19, 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 WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024, A PATIENT REQUIRED REVISION SURGERY DUE TO DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Subluxation

  MAUDE report 21644289 ↗
• InjuryJun 4, 2024Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "OPERATION DATE (B)(6) 2023. PATIENT USED REVIVE STEM WITH PERFORM REVERSE. REP OF THE CASE AS DEFINITELY SAID THERE WAS A LOCKING CAP USED. THE NURSE STRUGGLING INITIALLY WITH THE CAP AND SURGEON THEMSELVES TIGHTENING THE CAP. THE INITIAL XR THE STEM WAS STANDARD. 3 MONTH POST OP THE WAS A GAP BETWEEN PROXIMAL BODY AND DISTAL STEM (ON X-RAY). FINAL XR 7 MONTHS PO THE STEM IS NOW JOINED AGAIN. WE HAVE INQUIRED WHETHER THE PATIENT IS FEELING THESE SHIFTS AND WHETHER THE SURGEON WOULD LIKE TO GO AHEAD WITH THE REVISION AND ASKED IF THEY WILL CONDUCT MORE XRS UNDER COMPRESSION AND NOT TO SEE IF THE IMPLANT IS SHIFTING. LOCKING CAP WAS ON USAGE.".

  Patient problems: Inadequate Osseointegration

  MAUDE report 19464077 ↗
• 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 THE DISTAL HUMERUS ONLY AND NO EVIDENCE ON XR OF ANY SHOULDER JOINT ISSUE.

  Patient problems: Inadequate Osseointegration; Rheumatoid Arthritis; Unspecified Infection

  MAUDE report 19159669 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED A INTRAOPERATIVE GT FRACTURE WHICH WAS TREATED WITH SUTURE CERCLAGE.

  Patient problems: Limb Fracture

  MAUDE report 18388951 ↗
• InjuryAug 23, 2023Osseointegration Problem; Osseointegration Problem

  THE TORNIER SHOULDER OUTCOMES STUDY'S PATIENT EXPERIENCED A REVISION SURGERY DUE TO ISSUES WITH LOOSENING/LYSIS. DURING THE PROCEDURE, A GLENOID SPHERE WAS REMOVED AND REPLACED WITH A REVERSED-LATERALIZED GLENOSPHERE THAT WAS 3MM LARGER (39MM). AN ADDITIONAL UPDATE REVEALED THAT THE TORNIER HRS ARS741701 WAS ALSO REMOVED DURING THE SURGERY.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 17606936 ↗