Equinoxe 314-02-34Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862175113), received between Oct 4, 2019 and Aug 26, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K103419); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE. IT WAS REPORTED THAT THE GLENOID WAS COMPLETELY ERODED AND CAME OUT IN FRAGMENTS. ALL PIECES OF THE IMPLANT THAT REMAINED WERE REMOVED AND THE AREA WAS THOROUGHLY DEBRIDED. THE SURGEON HAD CONSIDERED KEEPING THE STEM, BUT UPON INSPECTION IT WAS LOOSE AND CAME OUT WITH MINIMAL EFFORT. THE PATIENT WAS REVISED TO A COMPETITOR'S DEVICES. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS WERE PROVIDED. NO DEVICES WERE NOT RETURNED FOR EVALUATION. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22899008 ↗
• InjuryDec 30, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 5 YEAR(S), 10 MONTH(S) AND 12 DAY(S) POST-OPERATIVE OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED A ASEPTIC GLENOID LOOSENING ¿ GLENOID FAILURE. IN AN EARLIER REPORTED EVENT, 18 DAYS POST OPERATIVELY THE PATIENT EXPERIENCED A HEMATOMA IN WHICH A WASHOUT PROCEDURE WAS PERFORMED IN THEATRE AND THE EVENT WAS RESOLVED. THE PATIENT UNDERWENT A STANDARD TOTAL REVISION FOR THE LOOSENING WITH THE REPORTED REMOVAL OF THE STANDARD HUMERAL STEM, REPLICATOR PLATE, TORQUE SCREW, HUMERAL HEAD, AND GLENOID COMPONENTS. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES, NO DEVICE RETURN IS ANTICIPATED, AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 21036230 ↗
• InjuryApr 22, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT A MALE PATIENT, INITIAL SHOULDER IMPLANTED ON (B)(6) 2012, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 11 YEARS 9 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS CONVERTED FROM AN ANATOMIC TO A REVERSE WITH A COMPETITOR¿S CUSTOM GLENOID. EXACTECH TRAY AND LINER WAS IMPLANTED WITH THE EXISTING STEM. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. NO EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. THE HOSPITAL KEPT THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 19160960 ↗
• InjuryAug 5, 2022Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THIS 71 YEAR OLD, FEMALE PATIENT HAD RIGHT TSA ON (B)(6) 2020. OVER TIME, PER THE SURGEON, THE PATIENT'S ROTATOR CUFF DETERIORATED AND THE INSTABILITY LED TO THE LOOSENING OF THE GLENOID COMPONENT. THE PATIENT WAS REVISED ON 7/14/2022. THERE WAS NO REPORTED DEVICE BREAKAGE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE INS TABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT RETURNING PER HOSPITAL POLICY.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 15178284 ↗
• InjuryOct 4, 2019Naturally Worn; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO POSSIBLE POLY WEAR, REASON NOT REPORTED.

  Patient problems: No Code Available; No Information

  MAUDE report 9156153 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103419. One submission often covers many models, so check the product and lot details in each record.

• Z-1406-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item
• Z-1407-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item