Equinoxe 314-02-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862175106), received between Dec 14, 2023 and Jul 6, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 18, 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.

• InjuryJul 6, 2026Naturally Worn

  IT WAS REPORTED THAT A PATIENT, WHO HAD RIGHT TSA UNDERWENT A 1ST STAGE REVISION PROCEDURE. BASED ON THE CT SCAN, IT APPEARS THAT THE HUMERAL HEAD WAS NO LONGER FULLY ARTICULATING ON THE POLY GLENOID AND HAS ERODED INTO THE POSTERIOR ASPECT OF THE GLENOID. THE 2ND STAGE WILL BE A CUSTOM-MADE GLENOID COMPONENT OWING TO THE SEVERITY OF BONE LOSS, RETAINING THE HUMERAL STEM. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGE DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Erosion

  MAUDE report 25725611 ↗
• InjuryMar 17, 2025Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY 8 YEARS 8 MONTHS POST INITIAL OPERATION. THE IMPLANTS WERE REMOVED DUE TO A ROTATOR CUFF TEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 21627492 ↗
• InjuryJan 13, 2025Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED. THE PATIENT HAD A HUMERAL RESURFACING AND OVER TIME THE GLENOID COMPONENT FAILED. THE SURGEON CARRIED OUT A 1ST STAGE REVISION WITH THE INTENT TO DO A 2ND STAGE INSERTING AN EXACTECH REVERSE SHOULDER. THE PATIENT HAS A CEMENT SPACER INSITU AND IS AWAITING A 2ND STAGE REVISION.

  Patient problems: Insufficient Information; Pain

  MAUDE report 21138025 ↗
• InjuryNov 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  STUDY: (B)(6) SUBJECT: (B)(4). IMPLANT DATE: (B)(6) 2013; EX-PLANT DATE: (B)(6) 2023; DATE OF EVENT ONSET: 01-30-2023. APPROXIMATELY 9 YEAR(S), 10 MONTH(S) AND 17 DAY(S) POST-OPERATIVE OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING WITH MECHANICAL CATCHING. THE PATIENT UNDERWENT A STANDARD TOTAL REVISION WITH THE REPORTED REMOVAL OF THE REPLICATOR PLATE. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE. THIS EVENT WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. CONCOMITANT DEVICE(S): 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM 2585154. 310-01-50 - EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA) 1631444. 314-02-33 - UHMWPE POST AUG GLENOID MEDIUM, RIGHT 2149790.

  Patient problems: Joint Impingement

  MAUDE report 20612692 ↗
• InjuryDec 14, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY ONE YEAR POST INITIAL RIGHT TSA, THE 59 Y/O MALE PATIENT WAS REVISED AS THE INITIAL IMPLANT WAS POORLY CEMENTED IN. THERE WAS NO CEMENT IN THE PEG HOLES TO HOLD THE IMPLANT IN PLACE. ALL COMPONENTS, EXCEPT FOR THE HUMERAL STEM, WERE REVISED. THE IMPLANTS WERE CHANGED FROM A SHOULDER ANATOMIC TO A SHOULDER REVERSE. A 36MM LINER WAS IMPLANTED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE DEVICES WERE DISPOSED AT HOSPITAL.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18331029 ↗

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