Equinoxe 308-01-11Recalls & 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 10885862267917), received between Sep 16, 2019 and Sep 16, 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
- Device Dislodged or Dislocated1
- Loose or Intermittent Connection1
- Patient-Device Incompatibility1
Patient problems
- Failure of Implant1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2019Loose or Intermittent Connection; Patient-Device Incompatibility; Device Dislodged or Dislocated
AS REPORTED, APPROXIMATELY 9 YEARS AND 3 MONTHS POST RIGHT SHOULDER IMPLANT, THE PATIENT HAD AN ACUTE EVENT WHERE THE GLENOID COMPONENT AND GEOSPHERE CAME AWAY FROM THE BONE. MANY ATTEMPTS AT RESCHEDULING A REVISION WERE MADE AND, ON THIS DAY, SHE CAME IN FOR A REVISION ARTHROPLASTY. THE SURGEON PLANNED ON PUTTING OUR LARGEST HUMERAL HEAD ONTO HER HRP HUMERAL SIDE, BUT DURING SURGERY HER GLENOID BONE WAS SO SMALL AND OTHER MAJOR STRUCTURES (CORACOID/ACROMIUM) WERE VIRTUALLY GONE. SURGEON WAS CONCERNED THE BIG BALL HEMI WOULD NOT BE CONTAINED WITHOUT THIS CEILING SO OPTED TO REMOVE THE HUMERAL SIDE HRP ALONG WITH EVERYTHING THAT WAS LOOSE FROM THE GLENOID, LEAVE PATIENT WITHOUT ANY IMPLANTS AND A RESECTION ARTHROPLASTY FOR PAIN RELIEF PURPOSES. PATIENT LEFT THE Operating Room IN STABLE CONDITION. THERE WAS NO DELAY TO THE SURGERY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Failure of Implant; Pain
MAUDE report 9069464 ↗
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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