TORNIER PERFORM™ HUMERAL SYSTEM DWX4SSRecalls & 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 00846832085514), received between Apr 18, 2024 and Mar 11, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (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
- Migration1
Patient problems
- Embolism/Embolus1
- Fever1
- Hematoma1
- Joint Dislocation1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
- Thrombosis/Thrombus1
Recent adverse event reports
The 2 most recent of 2 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 21572491 ↗InjuryApr 18, 2024Migration; Migration
IT WAS REPORTED THAT THE PATIENT HAD A DISLOCATION, POSSIBLY ATTRIBUTED TO NIGHT TERRORS AFTER THE INITIAL SURGERY. THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE POLY INSERT. DURING IMPACTION OF THE POLY IT WAS NOTED THAT IT WOULD NOT SEAT DESPITE REPEATED MALLETING OF THE IMPLANT. THIS CAUSED THE STEM TO SUBSIDE AS WELL AS THE POLY TO BE DAMAGED. THE STEM WAS REMOVED AND REPLACED WITH LONGER STEM AND A NEW POLY WAS IMPLANTED.
Patient problems: Joint Dislocation; No Clinical Signs, Symptoms or Conditions
MAUDE report 19140553 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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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