Easytech Anatomical Shoulder System 314-0034Recalls & reported problems
Fx Solutions · EASYTECH ANCHOR BASE TA6V Ø34 mm CEMENTLESS Ti/HA · Class 2 · Implant
All models of Easytech Anatomical Shoulder System (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03701037301470), received between Aug 5, 2021 and Apr 27, 2022 — classified as 5 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 16, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available4
- Device Dislodged or Dislocated1
- Loose or Intermittent Connection1
- Material Split, Cut or Torn1
Patient problems
- Insufficient Information4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO DISMANTLING. APPROXIMATELY 35 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 2 PEGS GLENOID, 1 CENTERED HEAD, 1 DOUBLE TAPER AND 1 ANCHOR BASE. THE SURGEON IMPLANTED 1 HUMERAL CUP Ø36+9, 1 GLENOID BASEPLATE, 1 CENTERED GLENOSPHERE WITH SCREW, 3 LOCKING SCREW AND 1 HUMELOCK STEM.
Patient problems: Insufficient Information
MAUDE report 14216738 ↗InjuryJan 12, 2022Material Split, Cut or Torn
PATIENT WAS REVISED ON (B)(6) 2021 DUE TO A CUFF TEAR. NO INFORMATION ON THE FIRST DATE OF SURGERY. THE SURGEON EXPLANTED DOUBLE TAPER, ANCHOR BASE, 2 PEG GLENOID. THE SURGEON IMPLANTED EXCENTERED GLENOSPHERE, TWO CORTICAL SCREW, TWO LOCKING SCREW, TWO STANDARD SCREW, POST EXTENSION, STEM SIZE 12 AND Ø36+3 CUP.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13234889 ↗InjuryNov 15, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2021 DUE TO LOOSENING. APPROXIMATELY ONE YEAR AFTER THE FIRST SURGERY. TH SURGEON EXPLANTED CENTERED HEAD 43/16, ANCHOR BASE Ø34, 2 PEG GLENOID AND DOUBLE TAPER. THE SURGEON IMPLANTED HUMERAL CUP 40+3, HUMERIS STEM SIZE 12, GLENOID BASE PLANTE AND CENTERED GLENOSPHERE WITH SCREW.
Patient problems: Insufficient Information
MAUDE report 12809739 ↗InjuryOct 22, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
PATIENT WAS REVISED ON (B)(6) 2021 DUE TO DISLOCATION. SURGEON EXPLANTED EASYTECH ANCHOR BASETA6V Ø34 MM CEMENTLESS, 3-4 PEGS GLENOID PE CEMENTED SIZE S AND REPLACED IT WITH A Ø135/145 36+9 CUP, HUMELOCK REVERSED TA6V CEMENTLESS GLENOID BASE PLANT TI/HA Ø24MM AND ECCENTRIC GLENOSPHERE.
Patient problems: Insufficient Information
MAUDE report 12679014 ↗InjuryAug 5, 2021Appropriate Device Problem Term/Code Not Available
THIS EVENT WAS A REVISION SURGERY FOR TOTAL SHOULDER ARTHROPLASTY REMOVAL THAT OCCURED APPROXIMATELY 6 YEARS AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE EASYTECH ANATOMIC SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED ALL THE COMPONENTS AND IMPLANTED A NEW PROSTHESIS FROM ANOTHER MANUFACTURER. HE EXPLANTED THE Ø34 ANCHOR BASE, THE Ø20 RESURFACING GLENOID, THE +0 DOUBLE TAPER AND THE 43X16 CENTERED HEAD.
Patient problems: Insufficient Information
MAUDE report 12279174 ↗
Other Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained devices
- Tornier Perform DWM003ATornier, Inc. · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained1 recall1 report
- Sidus® Stem-Free Shoulder 01.04555.500Zimmer GmbH · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained1 recall1 report
- DJO SURGICAL 520-08-021Encore Medical, L.P. · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained20 reports
- INHANCE 5200-00-036Depuy (Ireland) · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained17 reports
- Easytech Anatomical Shoulder System 314-0038Fx Solutions · Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained14 reports
- Tornier Simpliciti® Shoulder System 7122872Tornier, Inc. · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained9 reports
- GLOBAL ICON 1140-10-054Depuy (Ireland) · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained6 reports
- Sidus® Stem-Free Shoulder 01.04555.110Zimmer GmbH · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained6 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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