Equinoxe 300-30-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862515780), received between Jul 2, 2019 and Nov 25, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K162726); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT WHO HAD A LEFT TOTAL SHOULDER ARTHROPLASTY UNDERWENT A REVISION PROCEDURE 38 DAYS POST THE INITIAL PROCEDURE. DURING REMOVAL OF THE DEFINITIVE HUMERAL ADAPTOR TRAY, THE FIXATION OF THE PRESERVE STEM WAS COMPROMISED. THE HUMERUS WAS PREPPED FOR A STANDARD 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.

  Patient problems: Aseptic loosening

  MAUDE report 23645943 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE, DURING WHICH, THE PATIENT EXPERIENCED A FRACTURE OF PROXIMAL HUMERUS (CALCAR) DURING STEM INSERTION. A BONE GRAFT WAS USED ON THE HUMERAL CALCAR. X-RAYS TO BE PERFORMED AT 3-MONTH FOLLOW-UP. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 22715041 ↗
• InjuryJun 23, 2025Migration; Migration

  IT WAS REPORTED THAT A 70 YO FEMALE PATIENT, WHO HAD A PRIMARY RTSA IMPLANTED, UNDERWENT A REVISION PROCEDURE. THE PATIENT NOTICED ISSUES WITH MOTION. XRAYS WERE TAKEN AND SHOWED SUPERIOR SHIFT AND THE STEM IN VALGUS CAUSING SOME MEDIAL RESORPTION ON HUMERUS. THE SURGEON REVISED THE CAGE GLENOID TO A TORNIER BASEPLATE AND 36 GLENOSPHERE. THE STEM WAS WELL FIXED, SO HE LEFT IT IN. THE SURGEON REVISED THE HUMERAL COMPONENTS TO OUR HUMERAL TRAY AND LINER (+0MM HUMERAL ADAPTER TRAY, +2.5MM 36MM HUMERAL LINER, REVERSE TORQUE DEFINING SCREW KIT). THERE WAS A 45 MINUTE SURGICAL DELAY REPORTED WITH NO ADVERSE EVENT TO THE PATIENT. THE REPORT INDICATED THE GLENOID CAGE AND PEGS WERE SEEMINGLY NOT IN PLACE ON THE X-RAYS TAKEN AND THE DELAY WAS DUE TO THE REVISION SURGERY NEEDED. THERE WERE NO DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THE HOSPITAL KEEPS THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Osteolysis

  MAUDE report 22311685 ↗
• InjuryFeb 5, 2024Fracture; Fracture

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 73 YEAR OLD FEMALE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2018 AND PRESENTED WITH HUMERAL FRACTURE, 4 YEAR(S) AND 4 MONTH(S) POST INITIAL PROCEDURE ON (B)(6) 2022. PATIENT SLIPPED AND FELL ONTO LEFT SHOULDER. ADDITIONAL INFORMATION: PERIPROSTHETIC FRACTURE AT MID-PORTION OF PRESERVE HUMERAL STEM. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE AND DEFINITELY NOT RELATED TO THE PROCEDURE. THE REPORT ALSO INDICATES THAT THE ACTION TAKEN ON (B)(6) 2023 WAS SLING, NO AROM, AND RELATIVE REST. THE OUTCOME IS REPORTED AS RESOLVED ON (B)(6) 2023. DUE TO CLINICAL STUDY, NO DEVICES WILL BE RETURNED FOR EVALUATION. 1038671-2024-00153 : 300-30-10 - EQUINOXE PRESERVE STEM 10MM.

  Patient problems: Bone Fracture(s)

  MAUDE report 18645768 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT, WHO WAS UNDERGOING AN INITIAL SHOULDER IMPLANT SURGERY, WAS FOUND TO HAVE A HUMERUS FRACTURE. DURING THE PROCEDURE, THE SURGEON HAD PLACED THE CUT GUIDE AGAINST THE HUMERUS AND RESECTED THE HUMERAL HEAD. HE THEN BEGAN TO REAM THE HUMERUS WORKING THROUGH THE REAMERS. THE PATIENT HAS AN EXACTECH TOTAL SHOULDER ON THE CONTRALATERAL SIDE AND HAD A 15 STEM IN WHICH IS WHAT THE SURGEON WAS TARGETING, HE REACHED THE 15 REAMER AND WAS JUST FINISHING REAMING, WHEN HE FELT SOMETHING ON THE HUMERUS, SO HE STOPPED REAMING AND HAD XRAY COME IN. THEY TOOK AN IMAGE, AND THE DOCTOR NOTICED A FRACTURE APPROX. 20-30 MM BELOW THE TOP OF THE REAMER. HE EXPOSED THE FRACTURE AND DECIDED THE BEST PLAN OF ACTION WAS TO CLOSE THE WOUND AND ADDRESS THE FRACTURE THE NEXT DAY WHEN THE PROPER PLATES AND EQUIPMENT WERE AVAILABLE. HE ALSO CONTACTED HIS TRAUMA PARTNER AND SCHEDULED HIM TO HELP IN THE REPAIR OF THE FRACTURE. ON (B)(6) 2023 THE CASE BEGAN WITH BOTH SURGEON¿S ADDRESSING THE FRACTURE WITH A SMALL FRAG PLATE. THE FRACTURE REDUCED NICELY, AND THE SURGEON ALSO ADDED ON A LONGER PROXIMAL HUMERUS PLATE WITH SCREWS AND A KINKED SUPER CABLE PROXIMALLY. ONCE THE FRACTUR

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 17336821 ↗
• InjuryFeb 9, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA CLINICAL STUDY (INTRA-OP) THAT THE 80-YEAR-OLD WHITE MALE PATIENT EXPERIENCE (SEPTIC LOOSENING) ANTERIOR SHOULDER PAIN WITHOUT INJURY FOR 6 MONTHS. THE DATE OF EVENT ONSET IS (B)(6) 2022. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICE OR PROCEDURE. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

  Patient problems: Subclinical Infection

  MAUDE report 16338731 ↗
• InjuryJun 8, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS (B)(6) MALE PATIENT'S RIGHT SHOULDER WAS REVISED DUE TO LOOSENING. THE PATIENT'S PRESERVE STEM APPEARED TO BE LOOSE AT TIME OF REVISION. SURGEON REMOVED EXISTING EXACTECH IMPLANTS AND REPLACED THEM WITH A 42+4 GLENOSPHERE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT AVAILABLE FOR RETURN.

  Patient problems: Failure of Implant

  MAUDE report 14631518 ↗
• InjuryJul 2, 2019Device Dislodged or Dislocated

  INDEX SURGERY: (B)(6) 2019. X-RAYS SHOW STEM SUBSIDENCE. NO ACTION WAS TAKEN. THE CASE REPORT FORM INDICATES THE EVENT IS POSSIBLY RELATED TO DEVICES AND POSSIBLY RELATED TO PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8756365 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162726. One submission often covers many models, so check the product and lot details in each record.

• Z-0958-2019 · Dec 5, 2018 · Terminated
  Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumera