Equinoxe 300-01-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10885862079299), received between Apr 3, 2019 and Dec 1, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Fracture” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 71 YO FEMALE PATIENT, WHO HAD RIGHT RTSA IMPLANT PROCEDURE, HAD A MIDSHAFT HUMERAL FRACTURE DURING THE PROCEDURE. DURING FINAL PLACEMENT OF THE HUMERAL STEM, A SMALL FRACTURE ABOUT THE MEDIAL POSTERIOR CALCAR HAD OCCURRED DUE TO SIGNIFICANT SCLEROTIC BONE THROUGHOUT THE METAPHYSIS. FIBERTAPE CERCLAGE WAS USED TO REDUCE THE FX. THE REPORTED INFORMATION INDICATED THE OUTCOME WAS RESOLVED. THE REPORT ALSO INDICATED THAT BONE GRAFT WAS USED BEHIND THE BASEPLATE. HARVEST LOCATION: HUMERAL HEAD. ADDITIONAL PROCEDURES PERFORMED DURING THE INITIAL RTSA: BICEPS TENODESIS, ORIF OF PROXIMAL HUMERUS DISPLACED CALCAR FX. NO FURTHER INFORMATION.

  Patient problems: Periprosthetic fracture

  MAUDE report 23688785 ↗
• InjuryNov 3, 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 TSA (TOTAL SHOULDER ARTHROPLASTY) ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED A HUMERAL PERIPROSTHETIC FRACTURE AND AN INFECTION. AS A RESULT, THE SURGEON REMOVED ALL IMPLANTS AND REPLACED WITH A CEMENT SPACER AS PART OF THE FIRST-STAGE REVISION. THEY HAVE A SECOND-STAGE REVISION PLANNED IN THE FUTURE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 23458353 ↗
• InjuryJul 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 5 YEARS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED. ONE PEG AND CAGE ALSO DISSOCIATED AND WERE REMOVED. METALLOSIS WAS SEEN, MOST LIKELY DUE TO THE PEGS/CAGE BEING EXPOSED TO THE HEAD. THE STEM WAS LOOSE AS WELL. EXPLANTED ALL HARDWARE AND REVISED TO AN ANTIBIOTIC SPACER. ALL PARTS/PIECES WERE REMOVED FROM THE PATIENT. THERE WAS A 45 MINUTE SURGICAL DELAY, BUT NO ADVERSE EVENTS AS A RESULT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Metal Related Pathology

  MAUDE report 22554549 ↗
• InjuryMar 19, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE AND THEN EXPERIENCED A FAILED HEMIARTHROPLASTY APPROXIMATELY 15 YEARS AFTER INITIAL REPLACEMENT THAT RESULTED IN THE PATIENT UNDERGOING A RIGHT SHOULDER REVISION (MDR#: 1038671-2025-01626). SUBSEQUENTLY, APPROXIMATELY 7 YEARS AFTER THE REVISION, THE PATIENT EXPERIENCED ASEPTIC HUMERAL LOOSENING - LOOSE HUMERAL STEM. AS A RESULT, THE PATIENT IS SCHEDULED FOR A SECOND REVISION SURGERY THIS YEAR. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 21647127 ↗
• InjuryNov 19, 2024Loosening of Implant Not Related to Bone-Ingrowth; 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 20724473 ↗
• InjuryMay 14, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS 72 Y/O FEMALE PATIENT'S RIGHT SHOULDER REVISED DUE TO PAIN AND A LOOSE STEM. REVERSE IMPLANTS WERE ALL REMOVED, MINUS THE BASEPLATE BECAUSE IT WAS WELL FIXED, AND REVISED TO NEW EXACTECH IMPLANTS. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant; Implant Pain; Pain

  MAUDE report 19315895 ↗
• InjuryDec 7, 2023Fracture; Fracture

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2023. THE PATIENT PRESENTED DURING SURGERY ON (B)(6) 2023 FOR NON-DISPLACED HUMERAL NECK FRACTURE DURING REDUCTION. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO DEVICE AND TO PROCEDURE. OUTCOME IS RESOLVED ON (B)(6) 2023 BY TAKING THE FOLLOWING ACTION: TREATED WITH CABLE. DEVICES WILL NOT BE RETURNED DUE TO CLINICAL STUDY CASE. DUE TO CLINICAL STUDY, NO DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 18280355 ↗
• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS WAS THE 2ND RIGHT SHOULDER REVISION FOR A 68 Y/O MALE PATIENT DUE TO INFECTION. THE SURGEON REPLACED STEM WITH NEW ONE AND ANTIBIOTICS TO WAIT FOR SAMPLES BEFORE PROCEEDING WITH HRP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS NOT RETUNING, IT WAS DISPOSED OF BY THE HOSPITAL.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 15761108 ↗
• InjuryNov 3, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, FEMALE PATIENT HAD A PERIPROSTHETIC FRACTURE OF THE STEM. PATIENT WAS REVISED TO HRP. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS AND PHOTOS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY.

  Patient problems: Bone Fracture(s); Failure of Implant; Periprosthetic fracture

  MAUDE report 15720381 ↗
• InjuryMay 25, 2022Fracture; Fracture

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, 2 DAYS POST OP THE INITIAL TSA, THIS (B)(6) MALE PATIENT WAS REVISED DUE TO AN UNDIAGNOSED INTRA-OPERATIVE MIDSHAFT HUMERAL FRACTURE CAUSING LOOSENING OF THE HUMERAL STEM AND DISLOCATION. THE CASE REPORT FORM INDICATES THIS EVENT IS NOT RELATED TO DEVICES OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Bone Fracture(s)

  MAUDE report 14495193 ↗
• InjuryMay 24, 2022Fracture; Fracture

  AS REPORTED, 2 DAYS POST OP THE INITIAL TSA, THIS 80 Y/O MALE PATIENT WAS REVISED DUE TO A MIDSHAFT HUMERAL FRACTURE. UNDIAGNOSED INTRA-OPERATIVE HUMERAL FRACTURE CAUSING LOOSENING OF THE HUMERAL STEM AND DISLOCATION. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Bone Fracture(s)

  MAUDE report 14490990 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 8 YEARS POSTOP THE INITIAL RIGHT TSA, THIS (B)(6) Y/O OLD FEMALE PATIENT PRESENTED WITH RIGHT SHOULDER PAIN. IMAGING SHOWED THE STEM HAD LOOSENED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain

  MAUDE report 10679007 ↗
• InjuryJun 27, 2019Material Split, Cut or Torn

  PRIMARY SURGERY: (B)(6) 2007. THE PATIENTS CUFF TORE AND NEEDED TO BE CONVERTED TO A REVERSE.

  Patient problems: Failure of Implant

  MAUDE report 8739206 ↗
• InjuryApr 3, 2019Loose or Intermittent Connection

  REVISION DUE TO INFECTION. IT WAS INFECTED AND LOOSE.

  Patient problems: Unspecified Infection

  MAUDE report 8477877 ↗

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-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-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-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-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-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