Equinoxe® 320-55-01Recalls & reported problems
Exactech, Inc. · Central Screw Baseplate · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862625618), received between Feb 11, 2026 and Apr 1, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).
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
- Loosening of Implant Not Related to Bone-Ingrowth2
Patient problems
- Aseptic loosening2
- Osteolysis1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED VIA A CLINICAL STUDY, THAT A 62 YO MALE PATIENT, WHO HAD A STEMLESS TSA, WAS REPORTED TO HAVE ASEPTIC GLENOID LOOSENING. REVISION OCCURRED. THE STANDARD REVERSE HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, GLENOSPHERE LOCKING SCREW, AND GLENOID BASEPLATE WERE REMOVED. ALLOGRAFT WAS IMPACTED INTO THE GLENOID DEFECT. NO INTRA-OPERATIVE COMPLICATIONS OCCURRED. THE STUDY INDICATED THE EVENT WAS DEFINITELY RELATED TO THE DEVICES AND POSSIBLE RELATED TO THE PROCEDURE. OUTCOME INDICATES RESOLVED. NO FURTHER INFORMATION.
Patient problems: Aseptic loosening; Osteolysis
MAUDE report 24754214 ↗MalfunctionFeb 11, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN WITH NO ASSOCIATED TRAUMA. X-RAYS WERE TAKEN, SHOWING SIGNS OF ASEPTIC GLENOID LOOSENING. THE DEVICE REMAINS IMPLANTED AT THIS TIME. ADDITIONAL IMAGING WILL BE PERFORMED AT FOLLOW UP APPOINTMENT; THEREFORE, THE PATIENT'S OUTCOME IS CONSIDERED CONTINUING.
Patient problems: Aseptic loosening; Pain
MAUDE report 24315500 ↗
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.
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