Tornier HRSRecalls & reported problems across all models

We found 40 models of Tornier HRS by Tornier, Inc. in the FDA's device registry (GUDID). Together they are named in 176 adverse event reports in the FDA's MAUDE database, received between Apr 21, 2023 and Sep 18, 2026 — classified as 145 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (35 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Tornier HRS recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 5, 2026Open, Classified

   Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.

   Z-1769-2026 · Root cause: Labeling design · names 3 of these models · Recall details · FDA record ↗

Most reported Tornier HRS problems

Tornier HRS models

40 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Tornier HRS ARS1041101

  shoulder prosthesis, reverse configuration
  1 recall0 reports
• Tornier HRS ARS1041102

  shoulder prosthesis, reverse configuration
  1 recall0 reports
• Tornier HRS ARS10252

  TEMPLATE
  1 recall0 reports
• Tornier HRS ARS655101

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  25 reports
• Tornier HRS ARS655200

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  24 reports
• Tornier HRS ARS741701

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  18 reports
• Tornier HRS ARS741802

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  15 reports
• Tornier HRS ARS741801

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  14 reports
• Tornier HRS ARS741702

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  12 reports
• Tornier HRS ARS741703

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  8 reports
• Tornier HRS ARS655102

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  8 reports
• Tornier HRS ARS741704

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  5 reports
• Tornier HRS ARS741803

  shoulder prosthesis, reverse configuration
  5 reports
• Tornier HRS ARS342001

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  3 reports
• Tornier HRS ARS655104

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  3 reports
• Tornier HRS ARS1023305

  TEMPLATE
  3 reports
• Tornier HRS ARS980904

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  2 reports
• Tornier HRS ARS741804

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  2 reports
• Tornier HRS ARS741809

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  2 reports
• Tornier HRS ARS655103

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  2 reports
• Tornier HRS ARS1020603

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  2 reports
• Tornier HRS ARS1022801

  shoulder prosthesis, reverse configuration
  2 reports
• Tornier HRS ARS1023301

  TEMPLATE
  2 reports
• Tornier HRS ARS1023302

  TEMPLATE
  2 reports
• Tornier HRS ARS1023602

  TEMPLATE
  2 reports
• Tornier HRS ARS342002

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  1 report
• Tornier HRS ARS342004

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• Tornier HRS ARS342005

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• Tornier HRS ARS342008

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• Tornier HRS ARS741705

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• Tornier HRS ARS980902

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  1 report
• Tornier HRS ARS741807

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• Tornier HRS ARS741813

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  1 report
• Tornier HRS ARS1022802

  shoulder prosthesis, reverse configuration
  1 report
• Tornier HRS ARS1022803

  shoulder prosthesis, reverse configuration
  1 report
• Tornier HRS ARS1023303

  TEMPLATE
  1 report
• Tornier HRS ARS1023304

  TEMPLATE
  1 report
• Tornier HRS ARS1023306

  TEMPLATE
  1 report
• Tornier HRS ARS1023601

  TEMPLATE
  1 report
• Tornier HRS ARS1023603

  TEMPLATE
  1 report

Recent Tornier HRS adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryAug 17, 2026Device Dislodged or Dislocated; 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 50285844 ↗
• InjuryAug 4, 2026Device Dislodged or Dislocated

  A revision surgery was performed as a result of implant failure as the set screw backed out, decoupling the proximal body from the humeral stem which caused the patient pain.

  Patient problems: Arthritis; Inadequate Osseointegration; Metal Related Pathology; Nonunion/Delayed-union Bone Fracture; Pain; Perforation; Synovitis

  MAUDE report 50131508 ↗
• InjuryAug 4, 2026Device Dislodged or Dislocated

  A revision surgery was performed as a result of implant failure as the set screw backed out, decoupling the proximal body from the humeral stem which caused the patient pain.

  Patient problems: Arthritis; Inadequate Osseointegration; Metal Related Pathology; Nonunion/Delayed-union Bone Fracture; Pain; Perforation; Synovitis

  MAUDE report 50131245 ↗
• InjuryAug 4, 2026Device Dislodged or Dislocated

  A revision surgery was performed as a result of implant failure as the set screw backed out, decoupling the proximal body from the humeral stem which caused the patient pain.

  Patient problems: Arthritis; Inadequate Osseointegration; Metal Related Pathology; Nonunion/Delayed-union Bone Fracture; Pain; Perforation; Synovitis

  MAUDE report 50131243 ↗
• InjuryAug 4, 2026Migration

  A revision surgery was performed as a result of implant failure as the set screw backed out, decoupling the proximal body from the humeral stem which caused the patient pain.

  Patient problems: Arthritis; Inadequate Osseointegration; Metal Related Pathology; Nonunion/Delayed-union Bone Fracture; Pain; Perforation; Synovitis

  MAUDE report 50131240 ↗
• MalfunctionJun 16, 2026Mechanical Jam

  IT WAS REPORTED THAT THE ARS743000 WOULD GET STUCK ON THE PROXIMAL BODY TRIALS AFTER EVERY IMPACTION. ACCORDING TO THE STRYKER REP, THIS MADE THE TRIALLING VERY DIFFICULT (NEED A WAY TO LOOSEN HOW TIGHT THE HANDLE MATES ONTO THE PROXIMAL BODY TRIALS). ADDITIONAL INFORMATION FROM THE STRYKER REP MAY 21: "I TRIED THE HANDLE ON ONE OF OUR LTC PROXIMAL BODIES AND VICE-VERSA, AND IT TURNS OUT THAT THE HANDLE IS NOT THE PROBLEM AT ALL, IT WORKED PERFECTLY. THE PROBLEM IS WITH THE NEW PROXIMAL BODY TRIALS (ARS1023301-ARS1023306). THEY WERE STICKY ON THE OLD HANDLE AS WELL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25521989 ↗
• MalfunctionJun 16, 2026Mechanical Jam

  IT WAS REPORTED THAT THE ARS743000 WOULD GET STUCK ON THE PROXIMAL BODY TRIALS AFTER EVERY IMPACTION. ACCORDING TO THE STRYKER REP, THIS MADE THE TRIALLING VERY DIFFICULT (NEED A WAY TO LOOSEN HOW TIGHT THE HANDLE MATES ONTO THE PROXIMAL BODY TRIALS). ADDITIONAL INFORMATION FROM THE STRYKER REP MAY 21: "I TRIED THE HANDLE ON ONE OF OUR LTC PROXIMAL BODIES AND VICE-VERSA, AND IT TURNS OUT THAT THE HANDLE IS NOT THE PROBLEM AT ALL, IT WORKED PERFECTLY. THE PROBLEM IS WITH THE NEW PROXIMAL BODY TRIALS (ARS1023301-ARS1023306). THEY WERE STICKY ON THE OLD HANDLE AS WELL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25521882 ↗
• 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 8, 2026Detachment 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) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2026 A PATIENT REQUIRED REVISION SURGERY DUE TO COMPONENT DISSOCIATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Insufficient Information

  MAUDE report 25426225 ↗
• InjuryJun 8, 2026Detachment 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) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2026 A PATIENT REQUIRED REVISION SURGERY DUE TO COMPONENT DISSOCIATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Insufficient Information

  MAUDE report 25426224 ↗

Other Tornier, Inc. products

• Tornier Perform Reversed Glenoid41 models · 515 reports · 1 recall
• Tornier Perform40 models · 290 reports · 1 recall
• TORNIER PERFORM HUMERAL SYSTEM68 models · 190 reports · 1 recall
• Tornier Perform Reversed Augmented Glenoid8 models · 121 reports · 1 recall
• AEQUALIS FLEX REVIVE24 models · 70 reports · 2 recalls
• Latitude - Elbow35 models · 147 reports
• Tornier Latitude7 models · 14 reports · 1 recall
• Latitude EV24 models · 56 reports