TORNIER PERFORM™ HUMERAL SYSTEM DWR2390Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00846832084845), received between Jun 20, 2024 and Feb 2, 2026 — classified as 4 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 Problem3
- Device Dislodged or Dislocated1
- Positioning Failure1
Patient problems
- Unspecified Infection2
- Insufficient Information1
- Joint Dislocation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT: (B)(6). (B)(4) STUDY. REPLACEMENT OF THE COMPLETE PROSTHESIS DUE TO CHRONIC LOW-GRADE INFECTION. (LEUKOCYTES 8. G/L, CRP 17.7 MG/L, CELL COUNT: 12,300, 98% POLYNUCLEAR: MIBI FROM PUNCTURE: RENEWED DETECTION OF CUTIBACTERIUM ACNES IN THE CULTURE, PENICILLIN-SENSITIVE)
Patient problems: Unspecified Infection
MAUDE report 24232087 ↗InjurySep 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, USING THE BLUEPRINT PLANNING FEATURE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23175551 ↗InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "PHS STUDY SUBJECT: (B)(6). DEEP INFECTION REQUIRING A MEDICAL INTERVENTION (OPENED DEBRIDEMENT AND IRRIGATION). INFECTION C. ACNES RE-OPERATION WITHOUT IMPLANT EXTRACTION. DATE OF REOPERATION: (B)(6) 2025".
Patient problems: Unspecified Infection
MAUDE report 21948040 ↗InjuryJun 20, 2024Positioning Failure; Device Dislodged or Dislocated; Positioning Failure; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD TO UNDERGO A REVISION SURGERY THE SAME DAY AS THE INITIAL SURGERY DUE TO THE POLY NOT SEATING CORRECTLY AND DISLOCATING IN THE RECOVERY ROOM POST-OP.
Patient problems: Joint Dislocation
MAUDE report 19578286 ↗
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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