Tornier HRS ARS1020603Recalls & reported problems
Tornier, Inc. · PTC Proximal Body · Class 2 · Implant
All models of Tornier HRS (40)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832093960), received between Oct 15, 2025 and Nov 17, 2025 — classified as 2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Inadequacy of Device Shape and/or Size1
- Unstable1
Patient problems
- Fall1
- Joint Dislocation1
- Joint Laxity1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A REVISION SURGERY WAS PERFORMED AFTER THE PATIENT EXPERIENCED DISLOCATION AFTER A FALL.
Patient problems: Fall; Joint Dislocation
MAUDE report 23576296 ↗InjuryOct 15, 2025Inadequacy of Device Shape and/or Size; Unstable; Inadequacy of Device Shape and/or Size; Unstable
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RSA REVISION CASE DUE TO RESORPTION/STABILITY ISSUES WITH THEIR REVIVE STEM AND PERFORM REVERSE CONSTRUCT. THE STEM WAS SWAPPED FOR A LARGER CONSTRUCT. THERE WAS NO MECHANICAL FAILURES WITH THEM IMPLANT. THE DOCTOR BLAMED IT ON THE PATIENT CONDITION.
Patient problems: Joint Laxity
MAUDE report 23300205 ↗
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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