TORNIER PERFORM™ HUMERAL SYSTEM DWX2PLRecalls & 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 00846832085415), received between Mar 23, 2023 and Dec 17, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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
- Inadequacy of Device Shape and/or Size1
- Migration1
Patient problems
- Bone Fracture(s)1
- Fall1
- Insufficient Information1
- Subluxation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AFTER CEMENTING THE STEM TO THE HUMERUS, IT WAS CONFIRMED THAT THE RESULTING POSTERIOR ROTATION ANGLE DEVIATED FROM THE PLANNED ANGLE, NECESSITATING REINSERTION. THE CEMENT WAS BROKEN UP, THE STEM REMOVED, AND THE SAME STEM WAS REPOSITIONED AT THE CORRECT ANGLE BEFORE BEING CEMENTED IN PLACE ONCE MORE. AT THIS TIME, THE SLAP HAMMER DAMAGE REPORTED IN 0001649390-2025-00951 OCCURRED.
Patient problems: Insufficient Information
MAUDE report 23830735 ↗InjuryMar 23, 2023Inadequacy of Device Shape and/or Size; Migration; Inadequacy of Device Shape and/or Size; Migration
IT WAS REPORTED THAT A PATIENT HAD A REVERSE SHOULDER ARTHROPLASTY. PATIENT WAS HAVING SOME SUBSIDENCE OF THE STEM AT THEIR 1.5 WEEK FOLLOW-UP VISIT. PATIENT FELL AT 4 WEEKS POST-OP, PUSHING THE STEM DOWN FURTHER AND CAUSING A FRACTURE OF THE TUBEROSITIES. THE PROBLEM APPEARED TO BE WITH AN UNDERSIZED IMPLANT. THIS CAUSED SOME ASYMPTOMATIC SUBSIDENCE POST-OPERATIVELY. THE PATIENT FELL AT 4 WEEKS POST-OPERATIVELY. IT IS UNKNOWN IF THE SIZE OF THE HUMERAL STEM HAD ANY IMPACT ON THE FRACTURE CAUSED BY THE FALL. THE STEM WAS REMOVED AND A 3+ LONG WAS CEMENTED IN THE PATIENT. AS FAR AS I KNOW, YES. THE FALL COMPLICATED MATTERS. THE IMPLANT WAS INITIALLY USED FOR A STANDARD REVERSE SHOULDER ARTHROPLASTY. THE FRACTURE OCCURRED APPROXIMATELY 4 WEEKS AFTER THE PRIMARY SURGERY. THIS FRACTURE WOULD BE CONSIDERED AN A1. .
Patient problems: Bone Fracture(s); Fall; Subluxation
MAUDE report 16597569 ↗
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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