Tornier HRS ARS655104Recalls & reported problems
Tornier, Inc. · Assembly Screw · Class 2 · Implant
All models of Tornier HRS (40)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00846832093281), received between Dec 18, 2023 and Jul 30, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Loss of Osseointegration1
- Migration1
- Noise, Audible1
Patient problems
- Failure of Implant1
- Implant Pain1
- Inadequate Osseointegration1
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 22663452 ↗InjuryJun 5, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration
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 19466598 ↗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 (B)(6) 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 18352808 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page