Equinoxe 300-60-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862559296), received between Oct 10, 2024 and Dec 10, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Lack of Effect” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2024Lack of Effect; Lack of Effect

  APPROXIMATELY 3 YEAR(S), 8 MONTH(S) AND 14 DAY(S) POST-OPERATIVE OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. PATIENT DEVELOPED SHOULDER PAIN ABOUT 3 MONTHS AGO WITH INCREASING PAIN, CHANGING ROM, AND NIGHT PAIN. RADIOLUCENCY OVER GLENOID PEG AND PERI-HARDWARE; OSTEOLYSIS OVER STEMLESS HUMERAL COMPONENT. THE PATIENT WAS ADMINISTERED ESR/CRP TO RULE OUT INFECTION WITH PLAN FOR REVISION TO REVERSE (TYPE UNSPECIFIED) PENDING LABS. IN A RECENT UPDATE, THE PATIENT UNDERWENT A STANDARD TOTAL WITH STEMLESS REVISION, WITH THE REPORTED REMOVAL OF THE GLENOID, STEMLESS HUMERAL HEAD, AND STEMLESS HUMERAL CAGE COMPONENTS. THE OUTCOME OF THIS EVENT IS NOW CONSIDERED RESOLVED AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Inadequate Osseointegration; Loss of Range of Motion; Osteolysis; Pain

  MAUDE report 20895061 ↗
• InjuryOct 10, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 2 YEARS POST THE INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO LOOSENING. THE COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. THE PATIENT WAS NOT REVISED TO EXACTECH DEVICES. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20422598 ↗