Equinoxe 300-01-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862283016), received between Oct 11, 2021 and Aug 5, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (6 reports).

10 other recalls cover devices cleared under the same FDA submission (K042021); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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. SUBSEQUENTLY, THE PATIENT EXPERIENCED A PERIPROSTHETIC FRACTURE WITH HARDWARE BREAKAGE. A CABLE WAS REQUIRED FOR FIXATION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 22714453 ↗
• InjuryMay 27, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY TWO WEEKS POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT DISLOCATED FOR A SECOND TIME AND THE SURGEON DECIDED TO GO UP A SIZE ON THE STEM. THE STEM WAS ALSO LOOSE, BUT THE SURGEON BELIEVES THIS MAY HAVE HAPPENED DURING THE PREVIOUS CLOSED REDUCTION. 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.

  Patient problems: Inadequate Osseointegration; Joint Dislocation

  MAUDE report 22091074 ↗
• InjuryApr 22, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 82 MONTHS AFTER A TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING. BOTH THE HUMERAL STEM AND ANATOMIC CAGE GLENOID COMPONENTS WERE LOOSE. THE COMPONENTS WERE EASILY REMOVED AND THE SURGEON REIMPLANTED WITH COMPETITOR IMPLANTS. 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 ISSUES OR COMPLICATIONS WERE REPORTED. PHOTOS AND RADIOGRAPHS PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21881676 ↗
• InjuryJan 8, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 67 YO MALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 5 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE SURGEON REVISED THE PATIENT DUE TO A LOOSE STEM. ALL COMPONENTS IN THE HUMERUS WERE EXPLANTED AND THE GLENOID SIDE WAS LEFT ALONE. THEY WERE REVISED TO A COMPETITOR¿S DEVICES. X-RAYS WERE PROVIDED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS ARE ANTICIPATED AS THE HOSPITAL DOES NOT RELEASE THEM. A DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 18468853 ↗
• InjuryJul 5, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 4.4 YEARS POST INITIAL LEFT TSA, THE 77 Y/O FEMALE PATIENT HAD ALL IMPLANTS EXPLANTED DUE TO STEM LOOSENING. PATIENT WAS REVISED TO COMPETITOR'S DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS IMAGES RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL DOES NOT RELEASE IMPLANTS.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17261607 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA CLINICAL STUDY THAT INTRA-OPERATIVELY THE 77 YO FEMALE PATIENT HAD A GREATER TUBEROSITY FRACTURE DURING SURGERY. SEVERELY OSTEOPOROTIC BONE. SCARRING OF TUBEROSITY FROM PRIOR MINI-OPEN SURGERY. THE ACTION TAKEN WAS ORIF WITH SUTURES AROUND STEM. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2022.

  Patient problems: Bone Fracture(s); Limb Fracture

  MAUDE report 16493065 ↗
• InjuryApr 1, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 3.5 YEARS POST OP INITIAL RIGHT TSA, THIS (B)(6) Y/O MALE PATIENT WAS REVISED DUE TO INCREASING PERSISTENT PAIN IN OPERATIVE SHOULDER. SURGEON EXPRESSED CONCERN THAT THE HUMERAL STEM WAS LOOSE. INTRAOPERATIVELY, THE STEM WAS FOUND TO HAVE SOME SLIGHT MOVEMENT. THERE WAS NO SIGNIFICANT SIGN OF INFECTION BUT CULTURES WERE TAKEN. ALL HUMERAL COMPONENTS WERE REMOVED & REVISED. THE HUMERAL STEM WAS CEMENTED THIS TIME. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WERE KEPT BY HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 13976733 ↗
• InjuryOct 11, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THIS (B)(6) Y/O MALE PATIENT, 2 YRS POSTOP THE INITIAL L TSA, THE LEFT HUMERAL STEM BECAME LOOSE AND IT REVISED WAS REVISED. WE PUT IN A LONG REVISION STEM AND THE SAME SIZE REP PLATE AND HEAD. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT RETURN DUE TO FACILITY POLICY.

  Patient problems: Failure of Implant

  MAUDE report 12604572 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042021. One submission often covers many models, so check the product and lot details in each record.

• Z-0536-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: N
• Z-0537-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Compo
• Z-0535-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: N
• Z-1404-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Nu
• Z-1403-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Nu
• Z-1405-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02
• Z-1402-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item
• Z-0884-2021 · Nov 9, 2020 · Open, Classified
  Equinoxe Humeral Stem, Primary, Press Fit, 11mm
• Z-1459-2015 · Feb 13, 2015 · Terminated
  Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
• Z-2115-2012 · Jun 15, 2012 · Terminated
  Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty