TORNIER PERFORM™ HUMERAL SYSTEM DWP4393Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00846832084678), received between Aug 9, 2024 and Mar 11, 2025 — classified as 3 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 Problem2
- Device Dislodged or Dislocated1
Patient problems
- Embolism/Embolus1
- Fever1
- Hematoma1
- Joint Dislocation1
- Numbness1
- Pain1
- Thrombosis/Thrombus1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "SUBJECT: (B)(6) STUDY: SHOULDER ID. PATIENT PRESENTED TO ED (B)(6) 2025 S/P GENERALIZED WEAKNESS (SLID TO FLOOR FROM CHAIR) AND FEVER AND WAS FOUND TO HAVE ACUTE PE [PULMONARY EMBOLISM]. PATIENT HOSPITALIZED AT (B)(6) BEGINNING (B)(6) 2025. X-RAY OF R SHOULDER OBTAINED IN ED AND SHOWED INTACT HARDWARE WITHOUT COMPLICATION. (B)(6) 2025 - HEMATOMA - NARRATIVE: LEFT LOWER QUADRANT (LLQ) ABDOMINAL PAIN SECONDARY TO LARGE ACTIVE RECTUS SHEATH HEMATOMA IN THE SETTING OF NEW ANTICOAGULATION THERAPY. WARFARIN HELD AND REVERSED W/ VITAMIN K. PT REMAINS HOSPITALIZED. (B)(6) 2025: ACUTE DEEP VENOUS THROMBOSIS IN LEFT GASTROCNEMIUS VEINS. PT REMAINS HOSPITALIZED. OUTCOME: NOT RECOVERED/NOT RESOLVED".
Patient problems: Embolism/Embolus; Fever; Hematoma; Pain; Thrombosis/Thrombus
MAUDE report 21572487 ↗InjuryFeb 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "SUBJECT: (B)(6) SHOULDER ID STUDY. SENSORY AND/OR MOTOR DISTURBANCE - BRANCH NEUROPATHY PT REPORTED THAT ~2 WEEKS POST-OP, HE BEGAN EXPERIENCING NUMBNESS IN HIS RIGHT RING AND PINKY FINGERS."
Patient problems: Numbness
MAUDE report 21488523 ↗InjuryAug 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD TO UNDERGO A SECOND REVISION SURGERY DUE TO A DISLOCATION. TWO IMPLANTS WERE REPLACE TO PROVIDE PROPER TENSION IN THE SHOULDER.
Patient problems: Joint Dislocation
MAUDE report 19951226 ↗
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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