Equinoxe 314-13-33 (UDI 10885862658029)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
- 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 10885862658029), received between Apr 6, 2026 and Apr 27, 2026 — classified as 2 injuries.
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
- Fracture1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Aseptic loosening1
- Joint Dislocation1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2026Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED VIA CLINICAL STUDY THAT THIS PATIENT UNDERWENT A SHOULDER REPLACEMENT. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND WAS FOUND TO HAVE A DISPLACED GLENOID COMPONENT, ASEPTIC GLENOID LOOSENING, AND POLYETHYLENE COMPONENT DISSOCIATION. THE PEGS DISASSEMBLED. A REVISION SURGERY HAS BEEN RECOMMENDED BUT HAS NOT YET BEEN PERFORMED. THE DEVICE REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Aseptic loosening; Pain
MAUDE report 25006109 ↗InjuryApr 6, 2026Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER REPLACEMENT. SUBSEQUENTLY, THEY EXPERIENCED A DISLOCATION. THE PATIENT WAS ALSO FOUND TO HAVE A FRACTURED CAGED GLENOID COMPONENT. A REVISION PROCEDURE WAS PERFORMED, AND THE PATIENT WAS CONVERTED TO A REVERSE TOTAL SHOULDER REPLACEMENT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 24790354 ↗
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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