Tornier HRS ARS741802Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00846832093021), received between May 12, 2023 and Sep 18, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 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  The manufacturer received a report from the National Joint Registry that contains unpublished collected data on the usage and the outcomes of the shoulder joint replacement.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 50815430 ↗
• InjuryJun 16, 2026Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 MAY 2026. 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 25515977 ↗
• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 25404431 ↗
• 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 24556760 ↗
• 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 24413930 ↗
• 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 23686994 ↗
• 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 (B)(6) 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 22794907 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REVERSE SHOULDER ARTHROPLASTY WAS DONE FOR INFECTION. THE SURGEON MENTIONED ENTEROCOCCI WAS DETECTED. THE IMPLANTS WERE REMOVED AND CEMENT SPACER WAS IMPLANTED. NO PRODUCT FAULT WAS REPORTED.

  Patient problems: Bacterial Infection

  MAUDE report 22153999 ↗
• 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 MARCH 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 21594054 ↗
• InjuryFeb 24, 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 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) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO DISLOCATION AND SUBLUXATION WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: REVISION STEMMED TOTAL REVERSE ARTHROPLASTY.

  Patient problems: Subluxation

  MAUDE report 21453199 ↗
• 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 (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 19629097 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN ALONG THE ANTERIOR BASE OF THE INCISION. PATIENT WAS GIVEN AN INJECTION - 1ML KENALOG, 2ML LIDOCAINE, 7ML ROPIVACAINE.

  Patient problems: Pain

  MAUDE report 18383177 ↗
• InjuryOct 10, 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 17905770 ↗
• InjuryJun 26, 2023Device Dislodged or Dislocated; Osseointegration Problem; Device Dislodged or Dislocated; Osseointegration Problem

  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 17199814 ↗
• 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 16924434 ↗