Equinoxe 320-08-42Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862563729), received between Jul 11, 2024 and Oct 30, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Insufficient Information1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, APPROXIMATELY ONE YEAR AND EIGHT MONTHS POST TOTAL SHOULDER ARTHROPLASTY (TSA), THE PATIENT UNDERWENT A REVISION OF THE RIGHT HYBRID REVERSE SHOULDER DUE TO THE GLENOSPHERE AND GLENOSPHERE LOCKING SCREW BACKING OUT AWAY FROM A WELL FIXED REVERSE BASEPLATE. IT WAS NOTED THAT THE PATIENT WAS INVOLVED IN AN ATV ACCIDENT THAT MAY HAVE AFFECTED THE PROSTHESIS. THE SURGEON REPLACED THE GLENOSPHERE AND GLENOSPHERE LOCKING SCREW. THERE WAS NO REPORTED DEVICE BREAKAGE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Patient problems: Insufficient Information
MAUDE report 20569429 ↗InjuryJul 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT APPROXIMATELY 12 MONTHS AFTER A LEFT TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PAIN AND LOOSENING. THE SURGEON REMOVED A LOOSE EQUINOXE GLENOID BASEPLATE AND 42+4 GLENOSPHERE. HE REPLACED THEM WITH A COMPETITOR¿S DEVICES. THERE WAS NO REPORTED SURGICAL DELAY OR BREAKAGE OF A DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE UNABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE SENT TO SPD. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.
Patient problems: Pain
MAUDE report 19726545 ↗
Other Shoulder Prosthesis, Reverse Configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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.
How reports and recalls are matched · Editorial policy · Report an error on this page