Equinoxe 314-02-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862175090), received between Nov 5, 2024 and Nov 19, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 7 YEARS POST INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY (TSA), THE PATIENT UNDERWENT REVISION DUE TO SUSPECTED GLENOID LOOSENING. THE SURGEON PLANNED ON CONVERTING TO REVERSE; HOWEVER, WHILE ATTEMPTING TO DISASSOCIATE THE HUMERAL HEAD FROM THE REPLICATOR PLATE, THE STEM CAME LOOSE. EVERYTHING WAS REMOVED AND REPLACED BY A COMPETITOR PROSTHESIS. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20724571 ↗
• InjuryNov 5, 2024Naturally 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 WAS REVISED APPROXIMATELY 9 YEARS 9 MONTHS POST OP. REASON FOR REVISION WAS DUE TO ROTATOR CUFF TEAR LEADING TO SUPERIOR MIGRATION OF THE HUMERUS. PATIENT WENT FROM A TOTAL SHOULDER ARTHROPLASTY TO A REVERSE TOTAL SHOULDER ARTHROPLASTY. SURGEON LEFT SAME STEM INSITU; REMOVED REPLICATOR PLATE, ALL POLY GLENOID, TORQUE SCREW AND HUMERAL HEAD AND IN REPLACEMENT PLACED A BASEPLATE, SCREWS, GLENOSPHERE, ADAPTOR TRAY, HUMERAL LINER, REVERSE TORQUE SCREW. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 20613424 ↗

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