TORNIER PERFORM™ HUMERAL SYSTEM DWP3390Recalls & 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 00846832084609), received between Nov 5, 2025 and Dec 18, 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
- Naturally Worn1
Patient problems
- Erosion1
- Pain1
- Subluxation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6), SHOULDER ID STUDY. THE PATIENT CALLED THE (B)(6) 2025 TO REPORT HE "ACCIDENTALLY PICKED UP A GALLON CONTAINER AND HELD IT FOR ABOUT 2 MINUTES." HE REPORTED INCREASING PAIN IN HIS LEFT SHOULDER WITH MOVEMENT. HE SAID HE FELT AS IF HE WAS "BACK TO SQUARE 1" AS PRIOR TO THE SHOULDER SURGERY. THE SURGEON ORDERED X-RAYS (B)(6) 2025 AND DETERMINED THEY "LOOKED GOOD" AND SHE ADVISED THE PATIENT TO REST THE SHOULDER.
Patient problems: Pain
MAUDE report 23838737 ↗InjuryNov 5, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn
IT WAS REPORTED THAT THE REVISION WAS PERFORMED DUE TO DISLOCATION AND THE LINER FROM PRIMARY OPERATION APPEARED CHEWED UP ON ONE SIDE. NO FURTHER INFORMATION WAS PERFORMED.
Patient problems: Erosion; Subluxation
MAUDE report 23477853 ↗
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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