Equinoxe 300-30-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862515759), received between Jul 20, 2023 and Dec 16, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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. 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.

• InjuryDec 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVERSE TOTAL SHOULDER REVISION ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT'S HUMERAL STEM AND TORQUE DEFINING SCREW DISASSEMBLED WHICH RESULTED IN DISASSEMBLY OF THE HUMERAL TRAY AND HUMERAL STEM. AS A RESULT, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION APPROXIMATELY 2 YEAR AND 6 MONTHS AFTER INITIAL IMPLANTATION OF THE STEM AND 6 MONTHS AFTER THE FIRST REVISION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23819735 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  AS REPORTED, APPROXIMATELY 1 YEAR AND 1 MONTH POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT PRESENTED WITH PAIN. THE PATIENT IS AN AMPUTATION PATIENT AND HAS NO LEGS. THE SURGEON SUSPECTED HE HAD APPLIED TO MUCH PRESSURE TO HIS SHOULDERS. THE LINER WAS EXCHANGED. A PRESERVE STEM WAS PREVIOUSLY USED, WHICH HAD MOVED SLIGHTLY INTO VARUS. THE STEM WAS VERY WELL FIXED, SO JUST THE POLY WAS REVISED. THERE WAS NO ISSUE WITH THE POLY. 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. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Pain

  MAUDE report 22017891 ↗
• InjuryJun 28, 2024Unstable; Unstable; Device Dislodged or Dislocated

  APPROXIMATELY 1 YEAR 6 MONTHS AFTER AN INITIAL RIGHT TSA, THE PATIENT PRESENTED WITH INSTABILITY/SUBLUXATION FROM A ROTATOR CUFF TEAR AND SUPERIOR AND ANTERIOR MIGRATION OF THE HUMERAL HEAD. THE OUTCOME OF THIS EVENT WAS RESOLVED BY STANDARD TOTAL REVISION WITH PRESERVES STEM. THE CASE REPORT INDICATES THE EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE.

  Patient problems: Joint Dislocation; Joint Laxity; Muscle/Tendon Damage; Subluxation

  MAUDE report 19633430 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 71-YEAR-OLD MALE PATIENT HAD AN INITIAL RIGHT TSA ON 12-DEC-2020 AND PRESENTED WITH BONE FRACTURE, 3 YEAR(S) AND 10 MONTH(S) POST INITIAL PROCEDURE ON (B)(6) 2023. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND UNLIKELY RELATED TO THE PROCEDURE. THE REPORT ALSO INDICATES THAT THE ACTION TAKEN IS CONSIDERING OPEN REDUCTION INTERNAL FIXATION OF FRACTURE. THE OUTCOME OF THIS EVENT IS CONTINUING. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY.

  Patient problems: Bone Fracture(s); Limb Fracture

  MAUDE report 18727089 ↗
• InjuryJul 20, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL STUDY THAT THE 76 YO FEMALE PATIENT EXPERIENCED AN INTRA-OP, CALCAR NON-DISPLACED HUMERAL FRACTURE. THE DATE OF EVENT ONSET IS ON (B)(6) 2022. THERE WAS NO ACTION TAKEN. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2023.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 17366129 ↗

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