TORNIER PERFORM™ HUMERAL SYSTEM DWP4396Recalls & reported problems
Tornier, Inc. · Class 2 · Implant
All models of TORNIER PERFORM HUMERAL SYSTEM (68)
Data updated Oct 16, 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 00846832084685), received between Mar 15, 2023 and Jan 7, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Component Missing1
Patient problems
- Insufficient Information2
- Joint Dislocation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 7, 2026Device Dislodged or Dislocated
UPON 2-WEEK POST-OP VISIT, PERFORM HUMERAL POLY WAS FOUND TO BE DISASSOCIATED FROM THE PERFORM HUMERAL STEM.
Patient problems: Insufficient Information
MAUDE report 23994564 ↗InjuryMar 15, 2023Component Missing; Device Dislodged or Dislocated; Component Missing; Device Dislodged or Dislocated
THE PATIENT HAD TO COME BACK IN LESS THAN A WEEK AFTER THEIR INITIAL SURGERY TO HAVE A REVISION SURGERY TO HAVE THE DISASSOCIATED REVERSED INSERT EXPLANTED AND A NEW ONE IMPLANTED. UPON GETTING INTO THE REVISION SURGERY, THE POLY HAD INDEED DISASSOCIATED FROM THE HUMERAL STEM AND THERE APPEARED TO BE NO LOCKING RING INSIDE OF THE POLY.
Patient problems: Insufficient Information; Joint Dislocation
MAUDE report 16550434 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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