Equinoxe 308-01-13Recalls & 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 10885862267924), received between Jun 19, 2024 and Jun 19, 2024 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Medical device site infection1
- Pain1
- Septic loosening1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 1 YEAR(S) AND 3 MONTH(S) POST IMPLANTATION OF LEFT A THIRD REVISED TSA (PREVIOUS REVISION REPORTED ON MFR# 1038671-2024-01824), THE PATIENT PRESENTED WITH ASEPTIC HUMERAL LOOSENING. PATIENT HAD REVISION TO A HRP AND HAS NEVER HAD RELIEF OF PAIN. A BONE SCAN WAS OBTAINED WHICH WAS RETURNED SUSPICIOUS FOR LOOSE PROSTHESIS AND NON-SPECIFIC FOCAL INFECTION. THIS OUTCOME OF THE EVENT WAS RESOLVED TWO MONTHS LATER BY STANDARD REVERSE WITH HUMERAL RECONSTRUCTION STEM REVISION OF THE LEFT SHOULDER AND S/P ANTIBIOTIC SPACER PLACEMENT FIVE MONTHS FOLLOWING WITH CONTINUED LIFT SHOULDER PAIN. PLAN TO REVISE BACK TO RTSA W/HRP. PAIN COULD BE RESULT OF CONTINUED GLENOID WEAR FROM THE SPACER. THE CLINICAL REPORT INDICATES THAT THE EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND UNLIKELY RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.
Patient problems: Medical device site infection; Pain; Septic loosening; Unspecified Infection
MAUDE report 19568878 ↗
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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