Equinoxe 314-13-32 (UDI 10885862658012)Recalls & reported problems
Exactech, Inc. · Glenoid, Posterior Augment Cage Pegged, 8 degree, Right · Class 2 · Implant
All models of Equinoxe (305)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862658012), received between Feb 17, 2026 and Feb 17, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 17, 2026Detachment of Device or Device Component
A CLINICAL STUDY REPORTED THAT THE PATIENT INITIALLY UNDERWENT A TOTAL SHOULDER ARTHROPLASTY (TSA). SUBSEQUENTLY, THE PATIENT EXPERIENCED DISSOCIATION OF THE POLYETHYLENE COMPONENT. THE PATIENT SUSTAINED SEVERAL FALLS IN 2024; HOWEVER, THE RELATIONSHIP BETWEEN THESE EVENTS AND THE IMPLANT FAILURE CANNOT BE CONFIRMED. IN 2025, THE PATIENT REPORTED INCREASED SHOULDER PAIN, PROMPTING RADIOGRAPHIC EVALUATION, WHICH DEMONSTRATED GLENOID POLYETHYLENE SHEAR FAILURE OF THE TSA. AS A RESULT, THE SURGEON REVISED PRESERVE STEM, REPLICATOR PLATE, TORQUE SCREW, HUMERAL HEAD, GLENOID. THE OUTCOME IS CONSIDERED RESOLVED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Pain
MAUDE report 24365627 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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