Tornier HRS ARS741701Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00846832092703), received between Aug 23, 2023 and Sep 17, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18 most recent of 18 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  The manufacturer received a report from the National Joint Registry that contains unpublished collected data on the usage and the outcomes of the shoulder joint replacement.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 (b)(6) 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 50803924 ↗
• InjuryAug 18, 2026Device Dislodged or Dislocated; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  It was reported that the patient underwent implantation of a Revive device. Follow-up X-ray demonstrated that the set screw and locking cap had backed out, resulting in separation of the proximal body from the distal stem. The patient was subsequently scheduled for revision shoulder surgery.During the revision procedure, severe metallosis was observed. The proximal body was reported to have rotated around the central screw and distal stem, resulting in significant wear of the mating teeth on both the proximal body and stem. Metallosis was also noted beneath the glenosphere and baseplate. The baseplate was found to be grossly loose and was easily explanted during the procedure.

  Patient problems: Inadequate Osseointegration; Metal Related Pathology

  MAUDE report 50297234 ↗
• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 25024804 ↗
• 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 FRACTURE AND ASEPTIC LOOSENING HUMERUS AND IMPLANT FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s); Osteolysis

  MAUDE report 24414113 ↗
• 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 23687275 ↗
• 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 23550359 ↗
• 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. LATER, IT WAS REPORTED THAT: THE PRE OP REVISION X RAY TAKEN ON (B)(6) 2025 SHOWING PLASMA SPRAY PROXIMAL COATING HAS ERODED AS WELL AS THE PROXIMAL BODY DISASSOCIATING FROM DISTAL BODY. THE REMARKABLE CIRCUMSTANCES RELATED TO THE EVENT WAS MENTIONED AS INFECTION POTENTIALLY BUT HAS NOT BEEN CONFIRMED YET. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23110905 ↗
• 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 22993200 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). REVIVE HRS STUDY. PATIENT SEEN FOR SWELLING AND PAIN OF RIGHT SHOULDER (OPERATED SHOULDER) ACCORDING TO THE SURGEON, THIS EVENT IS NOT RELATED TO THE DEVICE OR THE SURGERY

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 22663396 ↗
• 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 DECEMBER 2013 ¿ FEBRUARY 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 21644291 ↗
• 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 21452797 ↗
• 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 21307571 ↗
• 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 20507633 ↗
• InjuryJun 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PATIENT EXPERIENCED A DISLOCATION DUE TO A LOOSE PROXIMAL BODY OF THE REVIVE STEM, POTENTIALLY CAUSED BY A BACKED-OUT ASSEMBLY SCREW AND LOCKING CAP. REVISION SURGERY WAS PERFORMED, REPLACING ALL COMPONENTS EXCEPT FOR THE DISTAL STEM. ADDITIONAL IMPLANTS USED INCLUDED TWO SPACERS, A LOW OFFSET HUMERAL TRAY, AND A POLY INSERT.

  Patient problems: Failure of Implant

  MAUDE report 19466024 ↗
• 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 19464078 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REVISION SURGERY WAS CONDUCTED IN RESPONSE TO AN INFECTION. AN UPDATE PROVIDED INDICATES A LACK OF INFORMATION REGARDING THE LOT NUMBERS FOR THE SCREWS USED. HOWEVER, IT WAS MENTIONED THAT THE INFECTION APPEARED TO BE LOCALIZED, AND THE PROCEDURE INVOLVED WASHING OUT AND EXCHANGING PARTS.

  Patient problems: Unspecified Infection

  MAUDE report 18779220 ↗
• InjuryDec 18, 2023Loss of Osseointegration; Noise, Audible; Loss of Osseointegration; Noise, Audible

  AS REPORTED: "PATIENT HAD A REVIVE (IMPLANT) PUT IN ON (B)(6) 2023. PATIENT CAME BACK COMPLAINING OF PAIN AND A CLICKING. DR. SCHEDULED FOR A REVISION ON 22 NOV 2023 AND IT WAS DISCOVERED THAT THE ASSEMBLY SCREW HAD COME LOOSE AND THE PROXIMAL BODY WAS ROTATING".

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 18352811 ↗
• 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 17602972 ↗