Equinoxe 320-10-46Recalls & reported problems
Exactech, Inc. · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862565846), received between Nov 26, 2024 and Nov 26, 2024 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 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.
MalfunctionNov 26, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
APPROXIMATELY 9 DAY(S) POST-OPERATIVE OF A RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED GLENOID/CORACOID FXS WHICH LOOSENED GLENOID. PATIENT DOES NOT REPORT INJURY, BUT GLENOID COMPONENT WAS FOUND TO HAVE SHIFTED AT INITIAL POST-OP APPOINTMENT. THE PATIENT UNDERWENT A STANDARD REVERSE WITH PRESERVE STEM REVISION WITH THE REPORTED REMOVAL OF THE HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, AND GLENOSPHERE LOCKING SCREW COMPONENTS. PATIENT WAS LEFT WITH RESECTION ARTHROPLASTY TO ALLOW BASEPLATE TO HEAL, REVISION ARTHROPLASTY COMPLETED THREE MONTHS FOLLOWING. THE OUTCOME OF THIS EVENT IS NOW CONSIDERED RESOLVED AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND DEFINITELY RELATED TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 20778754 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.