Equinoxe 308-01-08Recalls & reported problems
Exactech, Inc. · Class 2 · Implant
All models of Equinoxe (305)
Data updated Oct 18, 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 10885862267894), received between Dec 20, 2019 and Dec 20, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 20, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THIS (B)(6) PATIENT WITH AN AVERAGE BUILD HAD AN INITIAL SURGERY "A COUPLE YEARS AGO". THE REPORTED INDICATION FOR THE INITIAL IMPLANTATION WAS DUE TO REMOVAL OF A TUMOR IN THIS RIGHT SHOULDER (ONCOLOGY). ON (B)(6) 2019, IT WAS NOTED THAT THE DISTAL STEM HAD BECOME LOOSE. THE STEM, COLLAR AND PROXIMAL BODY WERE REVISED. THE TRAY HEIGHT WAS ALSO BUILT UP. ALL AVAILABLE INFORMATION HAS BEEN RECEIVED. DEVICES ARE NOT AVAILABLE FOR RETURNED. UPON REVIEW OF ALL THE INFORMATION, THE CAUSE OF THE LOOSENING IS LIKELY RELATED TO THE PATIENT¿S PREVIOUS CANCER WHICH LIKELY RESULTED IN POOR BONE QUALITY (PRE-EXISTING CONDITION).
Patient problems: Failure of Implant
MAUDE report 9503593 ↗
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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