TORNIER PERFORM™ HUMERAL SYSTEM DWX934Recalls & reported problems
Tornier, Inc. · Class 2 · Implant
All models of TORNIER PERFORM HUMERAL SYSTEM (68)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00846832085538), received between Apr 13, 2023 and Aug 22, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).
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 Dislocated4
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Joint Dislocation5
- Insufficient Information2
- Fall1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryAug 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT AFTER A FALL THE PATIENT EXPERIENCED DISASSOCIATION. THE POLY INSERT WAS REMOVED IN THIS CASE.
Patient problems: Fall; Joint Dislocation
MAUDE report 22877885 ↗InjuryAug 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THIS IS THE PATIENT¿S THIRD DISASSOCIATION, AND ON THIS OCCASION THE PATIENT CLAIMS THEY WOKE UP IN THE MORNING WITH THE JOINT DISLOCATED.
Patient problems: Joint Dislocation
MAUDE report 22877883 ↗InjuryAug 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THIS IS THE PATIENT¿S SECOND DISASSOCIATION, AND ON THIS OCCASION THE PATIENT CLAIMS THEY WOKE UP IN THE MORNING WITH THE JOINT DISLOCATED.
Patient problems: Joint Dislocation
MAUDE report 22877881 ↗InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT LIFTED ARM AND HEARD A POP. PATIENT UNDERWENT A REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 22862986 ↗InjuryApr 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT HAD A PRIMARY REVERSE SHOULDER ARTHROPLASTY AROUND 2020/21. THE PATIENT HAD A REVISION FOR INSTABILITY ON (B)(6) 2021 AND AGAIN ON (B)(6) 2022. THE PATIENT WAS CHOPPING WOOD AND CARRYING THE WOOD IN HIS AFFECTED ARM. THE PATIENT EXPERIENCED A DISLOCATION ON (B)(6) 2023. X-RAYS WERE TAKEN AT HIS LOCAL VA AND IT WAS EVIDENT THAT THE POLYETHYLENE LINER HAD DISASSOCIATED. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2023 TO REMOVE THE OLD LINER AND SPACER AND REPLACE WITH NEW ITEMS.
Patient problems: Insufficient Information; Joint Dislocation
MAUDE report 16765801 ↗InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD A PRIMARY REVERSE SHOULDER ARTHOPLASTY AROUND 2020/21. HE HAD A REVISION FOR INSTABILITY ON (B)(6) 2021 AND AGAIN ON (B)(6) 2022. THE PATIENT WAS CHOPPING WOOD AND CARRYING THE WOOD IN HIS AFFECTED ARM. HE EXPERIENCED A DISLOCATION ON (B)(6) 2023. X-RAYS WERE TAKEN AT HIS LOCAL VA AND IT WAS EVIDENT THAT THE POLYETHELENE LINER HAD DISASSOCIATED. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2023 TO REMOVE THE OLD LINER AND SPACER AND REPLACE WITH NEW ITEMS.
Patient problems: Joint Dislocation
MAUDE report 16736613 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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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