Tornier HRS ARS741813Recalls & reported problems
Tornier, Inc. · PTC Distal Stem · Class 2 · Implant
All models of Tornier HRS (40)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846832093137), received between Feb 4, 2025 and Feb 4, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Osseointegration Problem” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K191318); they may or may not involve this specific model.
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
- Osseointegration Problem1
Patient problems
- Inadequate Osseointegration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 21307313 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K191318. One submission often covers many models, so check the product and lot details in each record.
- Z-2020-2023 · Jun 12, 2023 · Open, ClassifiedAEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
- Z-2019-2023 · Jun 12, 2023 · Open, ClassifiedAEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
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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