Equinoxe 308-02-13Recalls & 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 10885862267986), received between Nov 26, 2024 and Nov 26, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Loss of Range of Motion1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 26, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
APPROXIMATELY 2 MONTH(S) AND 12 DAY(S) POST-OPERATIVE OF A RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. PATIENT NOTICED INCREASED PAIN AND DECREASED MOTION WITHOUT REPORTED INCITING EVENT. X-RAYS AND CT SCAN CONFIRM ASEPTIC GLENOID LOOSENING. IT WAS NOTED IN THE PATIENTS MEDICAL HISTORY, A FURTHER DIAGNOSIS OF HUMERAL STEM LOOSENING. THERE WERE ALSO NOTATIONS REGARDING PREVIOUS EVENTS OF EXTENSIVE DEBRIDEMENT; HEMIARTHROPLASTY (BIOLOGICAL GLENOID W/HUMERAL RESURFACING); REVISION OF HEMI TO TSA W/POLY GLENOID; REVISION TO RTSA W/ALLOGRAFTING TO GLENOID; AND REMOVAL OF IMPLANTS, ABX SPACER, AND DEBRIDEMENT PRIOR TO THE ONSET OF THE LOOSENING EVENT. THE PATIENT UNDERWENT STANDARD REVERSE WITH HUMERAL RECONSTRUCTION STEM REVISION WITH THE REPORTED REMOVAL OF THE TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, GLENOSPHERE LOCKING SCREW, GLENOID BASE PLATE, AND COMPRESSION SCREW/LOCKING CAP. THE PATIENT WAS BONE GRAFTED ON THE GLENOID SIDE USING ILIAC CREST AUTOGRAFT AND DONOR ALLOGRAFT. GLENOSPHERE WAS NOT PLACED. PATIENT WILL HAVE CT SCAN AT 3 MONTHS TO ASSESS HEALING. IF THERE IS CONSOLIDATION OF THE GRAFT AND THE BASEP
Patient problems: Loss of Range of Motion; Pain
MAUDE report 20777651 ↗
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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