Equinoxe 304-22-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862083395), received between May 25, 2021 and Aug 20, 2025 — classified as 1 death, 4 injuries.

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

4 other recalls cover devices cleared under the same FDA submission (K092900, K101909); 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 20, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED IN A CLINICAL SHOULDER STUDY THAT APPROXIMATELY 46 MONTHS AFTER A RIGHT REVERSE TOTAL SHOULDER REPLACEMENT, A PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING OF THE STEM. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22855639 ↗
• InjuryJun 2, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 23 MONTHS AFTER A TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING AND PAIN. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 22124465 ↗
• InjuryNov 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 1 YEAR(S) POST-OPERATIVE OF A RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC HUMERAL LOOSENING OF HUMERAL COMPONENT. THE PATIENT UNDERWENT FRACTURE REVERSE REVISION WITH THE REPORTED REMOVAL OF THE TORQUE SCREW, FRACTURE HUMERAL STEM, HUMERAL TRAY, HUMERAL LINER, AND GLENOSPHERE. THE OUTCOME OF THIS EVENT IS NOW CONSIDERED RESOLVED AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE(S) AND DEFINITELY RELATED TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20612266 ↗
• InjuryApr 17, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2022. THE PATIENT WAS REVISED TO A REVERSE SHOULDER ON (B)(6) 2023 DUE TO SHOULDER INSTABILITY. DURING FINAL REDUCTION OF REVERSE IMPLANTS, THE GLENOID CONSTRUCT FIXATION FAILED DUE TO POOR BONE QUALITY. THE REVERSE COMPONENTS WERE THEN REMOVED AND REPLACED WITH ANATOMIC HEMI COMPONENTS. 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 OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 16758732 ↗
• DeathMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS (B)(6) Y/O FEMALE PATIENT WITH NO PREVIOUS MEDICAL HISTORY, APPROXIMATELY 1 WEEK BEFORE SUFFERED A SHOULDER TRAUMA (HUMERAL HEAD) AND WAS UNDERGOING PROCEDURE FOR REPAIR. APPROXIMATELY 20 MINUTES AFTER THE PROCEDURE BEGAN, THE PATIENT EXPERIENCED A TENSION DROP & INCREASE OF CO2 WITHOUT ANY EXPLANATION. THE SURGEON WAS THEN INSERTING SUTURE WIRES INTO THE TUBEROSITIES SO THAT HE COULD FIX THEM AFTER THE IMPLANTATION OF THE STEM. THE IMPLANT WAS NOT YET PLACED AND THERE WAS NO CEMENT USED AT THIS TIME. THERE WAS HEART MASSAGE WITH DEFIBRILLATOR. ¿PATIENT CAME BACK¿ FINALLY SO THE ANATOMIC FX SHOULDER HAS BEEN IMPLANTED. AT THE END OF PROCEDURE, THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT AND DIED AFTERWARDS WITHIN THE DAY. ALL AVAILABLE INFORMATION HAS BEEN RECEIVED AT THIS TIME. IT WAS REPORTED THAT THE IMPLANT WAS NOT THE ROOT CAUSE.

  Patient problems: Insufficient Information

  MAUDE report 11881821 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092900, K101909. One submission often covers many models, so check the product and lot details in each record.

• Z-0307-2021 · Sep 25, 2020 · Terminated
  Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
• Z-0308-2021 · Sep 25, 2020 · Terminated
  Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
• Z-0873-2020 · Dec 3, 2019 · Terminated
  Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally matur
• Z-0872-2020 · Dec 3, 2019 · Terminated
  Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature