Equinoxe 308-10-05Recalls & reported problems
Exactech, Inc. · 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 10885862268129), received between Jul 3, 2019 and Jul 3, 2019 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
Patient problems
- Joint Dislocation1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A MALE PATIENT RECEIVED AN HRP PROSTHESIS DURING REVISION OF A COMPETITOR¿S DEVICE DUE TO OSTEONECROSIS OF THE PROXIMAL HUMERUS. DURING AN INITIAL REVISION ATTEMPT EARLIER THE SAME MONTH, AN INFECTION WAS FOUND, AND A SPACER IMPLANTED. THE TUBERCULII WERE FULLY NECROTIZED AND THE ROTATOR CUFF NOT RE-FIXABLE. DUE TO THIS, A LARGE PROXIMAL HUMERAL BODY IN 0°RETROVERSION AND A RTSA WAS IMPLANTED. AT THE TIME OF HIS LAST FOLLOW-UP, THE PATIENT WAS ABLE TO ELEVATE HIS ARM UP TO 120°, WITHOUT ANY SIGNIFICANT ROTATION POSSIBLE. ALTHOUGH SATISFIED WITH THE FUNCTION, THE JOINT TENDS TO DISLOCATE ANTERIORLY WHILE SLEEPING AND UNDER STRESS CAUSING ANTERIOR MOVEMENT OF THE PROXIMAL HUMORUS. THE SURGEON BELIEVES THIS IS DUE TO THE 0° RETROVERSION IN COMBINATION WITH A TOO LARGE PROXIMAL HUMERUS AND IS PLANNING TO IMPLANT A SMALLER SIZE OF THE PROXIMAL HUMERUS IN CONNECTION WITH MORE RETROVERSION AND INCREASE STABILITY WITH THE HELP OF THE REVERSE IMPLANTS IN THE FUTURE.
Patient problems: Joint Dislocation; Unspecified Infection
MAUDE report 8758403 ↗
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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