Tornier HRS ARS342001Recalls & reported problems
Tornier, Inc. · Spacer · 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 00846832092581), received between Dec 18, 2023 and Jun 4, 2024 — 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
- Device Dislodged or Dislocated1
- Loss of Osseointegration1
- Noise, Audible1
- Osseointegration Problem1
Patient problems
- Inadequate Osseointegration2
- Failure of Implant1
- Implant Pain1
- Rheumatoid Arthritis1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 4, 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 9X20 SPACERS, A LOW OFFSET HUMERAL TRAY, AND A 36+9 POLY INSERT.
Patient problems: Failure of Implant
MAUDE report 19464271 ↗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 19159479 ↗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 18352813 ↗
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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.
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