TORNIER PERFORM™ HUMERAL SYSTEM DWP1390Recalls & 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
- 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 00846832084425), received between Mar 20, 2024 and Aug 13, 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
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
Patient problems
- Joint Dislocation1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2024. APPROXIMATELY ONE YEAR LATER, THE PATIENT VISITED THE HOSPITAL DUE TO SUSPECTED INFECTION. ALTHOUGH THE CONDITION WAS INITIALLY MANAGED WITH MEDICATION, 2ND SURGERY WAS PERFORMED IN (B)(6) 2025 TO REOPEN AND IRRIGATE THE SURGICAL SITE. DUE TO PERSISTENT INFECTION, A 3RD SURGERY WAS PERFORMED ON (B)(6) 2025. ACCORDING TO THE SURGEON, THERE WAS NO LOOSENING OF THE STEM AND BASEPLATE FIXED WITHIN THE BONE, AND NO SIGNS OF INTRAMEDULLARY INFECTION. THEREFORE, ONLY THE EXTERNAL IMPLANT COMPONENTS¿THE INSERT AND SPHERE¿WERE REMOVED. THE WOUND WAS THOROUGHLY IRRIGATED USING A BRUSH, AND NEW IMPLANTS OF THE SAME SIZE WERE REINSERTED BEFORE CLOSING THE SURGICAL SITE. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 22795554 ↗InjuryMar 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS DISCOVERED THAT THE ARTIFICIAL SHOULDER JOINT INSERT THAT WAS IMPLANTED ON (B)(6) HAD DISLOCATED FROM THE STEM ONE WEEK AFTER SURGERY. THE SCHEDULED REVISION DATE IS CURRENTLY UNDER REVIEW.
Patient problems: Joint Dislocation
MAUDE report 18942707 ↗
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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