Equinoxe 320-32-40Recalls & reported problems
Exactech, Inc. · Glenosphere, Lateralized · 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 10885862534989), received between Dec 22, 2021 and Nov 1, 2022 — 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
Patient problems
- Failure of Implant1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 71 YO FEMALE PATIENT, WHO HAD AN INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2021, UNDERWENT A 2-STAGE REVISION. 1ST REVISION ON (B)(6) 2022. 2ND REVISION ON (B)(6) 2022 DUE TO INFECTION. THE GLENOSPHERE, GELOSPHERE LOCKING SCREW, HUMERAL LINER WAS REPLACED. THEY WERE REVISED TO EXACTECH DEVICES. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT THE EXPLANTED DEVICES WILL NOT BE RETURNED DUE TO HOSPITAL POLICY. NO ADDITIONAL INFORMATION. OTHER REVISION REPORTED UNDER 1038671-2022-01251.
Patient problems: Unspecified Infection
MAUDE report 15708996 ↗InjuryDec 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, APPROXIMATELY 2 MONTHS POST OP THE INITIAL RTSA, THIS (B)(6) MALE PATIENT WAS REVISED DUE TO THE GLENOSPHERE LOCKING SCREW BACKING OUT CAUSING THE GLENOSPHERE TO BE LOOSE. THE ORIGINAL GLENOSPHERE AND GLENOSPHERE LOCKING SCREW WERE EXPLANTED AND NEW HARDWARE REPLACED THE EFFECTED IMPLANTS. THERE WAS A SMALL SURGICAL DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING DUE TO HOSPITAL POLICY.
Patient problems: Failure of Implant
MAUDE report 13060106 ↗
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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