Equinoxe 300-01-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10885862079336), received between May 31, 2019 and Sep 18, 2026 — classified as 13 injuries, 1 malfunction.

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 18, 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.

• InjurySep 18, 2026Detachment of Device or Device Component

  Patient problems: Pain

  MAUDE report 50819099 ↗
• InjuryAug 3, 2026Loosening of Implant Not Related to Bone-Ingrowth

  As reported, approximately 11 years and 2 months post the initial left total shoulder arthroplasty, the patient was revised due to the stem and glenoid loosening over time. 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: Insufficient Information

  MAUDE report 50113377 ↗
• InjuryDec 31, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 9 YEARS POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT REPORTED THAT PAIN AND WEAKNESS HAS BEEN CONSTANT FOR A WHILE. THE PATIENT REPORTEDLY TRIED TO CATCH SOMETHING AND FELT SOMETHING "TEAR OR SNAP", CAUSING INSTANT SHARP PAIN. THEY THEN NOTICED POPPING IN THE SHOULDER WHILE ATTEMPTING TO BUTTON THEIR PANTS. THE PATIENT'S HUMERUS WAS OBSERVED ON X-RAY TO BE THINNING PROXIMALLY, AND A SCALLOPING HUMERAL INTERFACE. THE SURGEON ASSESSMENT WAS THAT THE PATIENT SUFFERED ATRAUMATIC LOOSENING OF THE HUMERAL STEM. THE SHARP PAIN WAS BELIEVED TO BE THE RESULT OF THE HUMERAL COMPONENTS SHIFTING DURING MOVEMENT. THE HUMERAL COMPONENTS WERE REMOVED ALL IN ONE PIECE, CONFIRMING THAT THEY WERE LOOSE. THE WEAKENED CORTICAL BONE WAS FOUND BE FRACTURED. IT IS UNCLEAR IF THIS OCCURRED PRIOR TO OR DURING THE REVISION SURGERY. A REVISION STEM WAS CEMENTED IN AND THE FRACTURE WAS REDUCED WITH CABLES. TRAY AND LINERS WERE TRIALED AND IMPLANTED. THE PATIENT WAS STABILIZED WITH A +10 TRAY & 42MM +0 CONSTRAINED LINER. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING

  Patient problems: Aseptic loosening; Bone Fracture(s); Pain

  MAUDE report 23933413 ↗
• InjuryJul 11, 2025Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAS HAD MANY PREVIOUS SURGERIES ON THEIR RIGHT SHOULDER, STARTING WITH SCOPES AND THEN A HEMI ARTHROPLASTY THAT WAS CONVERTED TO AN EQUINOXE PRIMARY TOTAL SHOULDER. THE PATIENT WAS NEVER SATISFIED WITH THEIR SHOULDER OUTCOMES AND REPORTED PAIN, STIFFNESS, AND DECREASED MOTION. THE PATIENT PRESENTED TO THE SURGEONS OFFICE WITH THESE COMPLAINTS. THE SURGEON SCHEDULED THE PATIENT FOR REVISION PRIMARY TOTAL SHOULDER TO A COMPETITORS REVERSE SHOULDER ARTHROPLASTY. THE SURGEON ANTICIPATED THE IMPLANTS BEING LOOSE. THE PATIENT HAD SURGERY WHERE THE SURGEON REMOVED THE EQUINOXE PRIMARY IMPLANTS AND GLENOID ANCHORS SHOWN ON THE X-RAY. HE CULTURED AND IRRIGATED THE JOINT/WOUND AND REIMPLANTED A COMPETITORS REVERSE TSA CONSTRUCT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Pain

  MAUDE report 22480512 ↗
• InjuryMay 19, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED APPROXIMATELY 43 MONTHS POST RIGHT TOTAL SHOULDER ARTHROPLASTY; THE PATIENT UNDERWENT A REVISION PROCEDURE. INTRAOPERATIVELY, THE SURGEON OBSERVED THE POLYETHYLENE COMPONENT WAS DISASSEMBLED, CAUSING THE TRAY AND SPHERE TO ARTICULATE TO THE POINT OF WEARING THROUGH THE TRAY CAUSING METALLOSIS. IT WAS NOTED THAT THE PARTS, PIECES AND FRAGMENTS WERE REMOVED FROM THE PATIENT'S WOUND SITE. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REPORTED. THERE WERE NO MEDICAL OR OPERATIVE REPORTS PROVIDED. POST OPERATIVE PHOTOS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Metal Related Pathology

  MAUDE report 22044924 ↗
• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 10 YEAR(S) POST-OPERATIVE OF A RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED A HUMERAL FRACTURE ¿ TUBEROSITY. PATIENT HAS SPONTANEOUS ONSET OF HUMERAL STRESS FRACTURE AT THE BASE OF TUBEROSITY. NO ACTIONS WERE TAKEN AS A RESULT OF THIS EVENT AND THE OUTCOME IS CONSIDERED CONTINUING. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE(S) AND DEFINITELY NOT RELATED TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES, NO DEVICE RETURN IS ANTICIPATED, AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s); Limb Fracture

  MAUDE report 21561397 ↗
• InjuryOct 30, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 63 YO MALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED IN (B)(6) 2024, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 9 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT HAD REPORTED PAIN. THE SURGEON SUSPECTED THAT THE HUMERUS STEM HAD COME LOOSE. AFTER OPENING AND EXPLORING, IT WAS FOUND THAT THE STEM HAD COME LOOSE. THE SURGEON CEMENTED IN A NEW 15MM STEM WITH THE SAME IMPLANTS. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISCARDED AT THE HOSPITAL. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 20571982 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE MALE PATIENT HAD AN EQUINOXE STEM AND COMPETITOR'S CUSTOM GLENOID COMPONENT IMPLANTED IN HER RIGHT SHOULDER IN 2016 AND MULTIPLE INFECTIONS OVER THE YEARS. THE PATIENT WAS REVISED ON (B)(6) 2023. EVERYTHING WAS REMOVED AND A SPACER WAS PLACED IN-SITU. THERE WAS NO REPORTED BREAKAGE OF 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: Bacterial Infection; Unspecified Infection

  MAUDE report 16782146 ↗
• InjuryJan 11, 2023Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 69 Y/O MALE PATIENT EXPERIENCED HUMERAL FRACTURE. PATIENT HAD META/DIAPHYSEAL FRACTURE REMOVING WELL FIXED STEM DUE TO TRAY FAILURE. THE EVENT IS STILL ONGOING.

  Patient problems: Bone Fracture(s)

  MAUDE report 16142506 ↗
• InjuryNov 7, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS 72 Y/O MALE PATIENT WAS REVISED DUE A PERIPROSTHETIC FRACTURE OF THE LEFT HUMERAL STEM. SURGEON REMOVED THE PATIENT'S GLENOSPHERE, LINER, TRAY AND STEM. HE IMPLANTED A 42+4 GLENOSPHERE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 15742783 ↗
• InjuryDec 14, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THIS (B)(6) Y/O FEMALE PATIENT WAS PREVIOUSLY REVISED ON (B)(6) 2020 FOR WITH A LOOSE HUMERAL COMPONENT FROM A SUSPECTED INFECTION. CURRENTLY, PATIENT'S STEM IS LOOSE. REMOVED HUMERAL COMPONENTS AS WELL AS GLENOSPHERE, LOCKING SCREW AND COMPRESSION SCREWS. REPLACED ALL SHOULDER COMPONENTS. THE PATIENT HAS A BMI OF 50+. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT RETURN DUE TO FACILITY POLICY.

  Patient problems: Failure of Implant

  MAUDE report 13003206 ↗
• InjuryApr 29, 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 HAD A RIGHT TSA WITH ANATOMIC IMPLANTS IN (B)(6) 2013. RIGHT SIDE WAS SCHEDULED FOR REVISION TO REVERSE SHOULDER (B)(6) 1ST DUE TO PAIN AND SIGNS OF STEM LOOSENING. THE GLENOID LOOKS GOOD ON CT PER SURGEON. DURING THE OPERATION AFTER REMOVING THE STEM, THE ANESTHESIOLOGIST REQUESTED TO STOP THE OPERATION IF POSSIBLE DUE TO SOME ISSUES. IT WAS DISCUSSED AND THOUGHT THE BEST PLAN WAS TO PUT A TEMPORARY SPACER AND LEAVE THE GLENOID AND POSTPONE THE FULL CONVERSION TO REVERSE UNTIL LATER. TODAY, THE PATIENT UNDERWENT REMOVAL FROM OF THE SPACER WHICH HAD BEEN ARTICULATING WITH THE CAGED GLENOID THAT WAS LEFT BEHIND IN PLACE. THE GLENOID WAS STILL FIXATED WELL AND WAS WORN BUT NOT BAD PER SURGEON. REVISION WENT ¿VERY WELL¿ ACCORDING TO THE SURGEON. THERE IS A SLIGHT CHANCE THAT THE HOSPITAL CAN RELEASE THE GLENOID TO EXACTECH. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 11743896 ↗
• MalfunctionMar 3, 2021Device-Device Incompatibility; Device-Device Incompatibility

  AS REPORTED, DURING IMPACTION PHASE OF THE PROCEDURE ON THIS (B)(6) Y/O MALE PATIENT, THE IMPLANT, BROACH TRIAL, AND REAMER FOR A SIZE 15 DID NOT MATCH SIZES AND SURGEON ENDED UP HAVING A SUBSIDED STEM. "SPECIFICALLY TRIAL AND REAL IMPLANT." THE SURGEON HAD TO REAM THE CANAL AGAIN AND BROACH UP A SIZE IN ORDER TO GET IMPLANT TO FIT. CREATED A STRESSFUL SITUATION FOR SURGEON. THIS CREATED A SHORT DELAY WITH NO HARM TO THE PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE TO RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404350 ↗
• InjuryMay 31, 2019Appropriate Device Problem Term/Code Not Available

  REVISION DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8659402 ↗

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 Compone
• 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
• 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 Compone
• 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-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-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-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