TORNIER PERFORM™ HUMERAL SYSTEM DWX1SSRecalls & 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 00846832085408), received between Feb 28, 2025 and Nov 13, 2025 — classified as 2 injuries.
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
Patient problems
- Bone Fracture(s)1
- Implant Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A COMPETITOR'S ARTIFICIAL HUMERAL HEAD WAS IMPLANTED, BUT DUE TO DIFFICULTY WITH ELEVATION, IT WAS REPLACED WITH A STRYKER RSA. DURING THIS PROCEDURE, TO REMOVE THE COMPETITOR'S STEM, IT WAS NECESSARY TO SEPARATE THE GREATER TUBERCLE FROM THE SHAFT. SUBSEQUENTLY, THE GREATER TUBERCLE GRADUALLY FRACTURED OR RATHER, IT MIGRATED. IT WAS REPORTED THAT THE PATIENT HAD A FRACTURE OF THE GREATER TUBERCLE AROUND THE STEM. DEBRIDEMENT WAS PERFORMED ON (B)(6). BONE FRAGMENTS AND CEMENT PARTICLES WERE REMOVED. WHILE THERE WERE NO ISSUES WITH STABILITY, THE PROCEDURE CONCLUDED BY FILLING THE SLIGHT GAP BETWEEN THE STEM AND THE PROXIMAL END WITH CEMENT. BUT THEN DISLOCATION WAS FOUND, AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2025.
Patient problems: Bone Fracture(s)
MAUDE report 23550084 ↗InjuryFeb 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "UNEXPECTED PAIN (ASSESSED AS NOT RELATED TO SURGICAL RECOVERY BY THE PRINCIPAL INVESTIGATOR): PRESENTS WITH COMPLAINTS OF ANTERIOR SHOULDER PAIN LOCALIZED TO MEDIAL TO INCISION, PROBABLY SECONDARY TO CONJOINT TENDONITIS. STEROID INJECTION (B)(6)2024, PROVIDED 6 WEEKS OF RELIEF. SCHEDULED FOR RELEASE OF CONJOINED TENDON."
Patient problems: Implant Pain
MAUDE report 21488520 ↗
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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