Equinoxe 310-01-44 (UDI 10885862083876)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862083876), received between Apr 3, 2019 and Aug 18, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY SEVEN YEARS POST INITIAL RIGHT TSA, THE PATIENT EXPERIENCED A ROTATOR CUFF TEAR AFTER PRIMARY TOTAL SHOULDER ARTHROPLASTY. PATIENT WAS REVISED TO A REVERSE TOTAL SHOULDER ARTHROPLASTY, WHILE RETAINING THE ORIGINAL STEM. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS RECEIVED. SALES REP WAS UNABLE TO OBTAIN IMAGES. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL KEEPS EXPLANTS.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 22834099 ↗
• InjuryAug 5, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 87 MONTHS AFTER A RIGHT TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS GLENOID POLY FAILURE AND PAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. AN IMAGE OF THE DEVICES WAS PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 22719193 ↗
• InjuryJul 16, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 3 YEARS AFTER THE INITIAL LEFT TSA, THE 68-YEAR-OLD FEMALE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO INCREASED PAIN IN HER SHOULDER WITHIN THE LAST YEAR. ONCE THE INCISION WAS MADE, THE SURGEON NOTICED SOME BLACK BUBBLES SURROUNDING THE SUTURES. ONCE WE GOT A LITTLE DEEPER, THE HUMERAL HEAD WAS REMOVED ALONG WITH THE REPLICATOR PLATE AND SCREW. THE SURGEON DECIDED TO LEAVE THE STEM ALONE AND MOVE ON TO REMOVING THE CAGED GLENOID. HE WAS ABLE TO REMOVE IT WITH JUST THE SUCTION CATHETER AS IT HAD SNAPPED FROM THE CAGE. CAGE WAS REMOVED WITH THREADED CAGE EXTRACTOR ON A SLAP HAMMER. THERE WAS A LOT OF GLENOID BONE LOSS AND MEDIALIZATION. OUR EXTENDED CAGE IMPLANT WAS USED ALONG WITH OUR SCREWS AND A 36MM +4MM LATERALIZED GLENOSPHERE. OUR TRIALS WERE SPINNING ON THE STEM IMPLANT THAT WAS LEFT IN PLACE WHEN TRAILING THE LINER AND TRAY. WE OPENED UP IMPLANTS AND THEY WERE SPINNING AS WELL ON THE STEM IMPLANT. BECAUSE OF THIS WE WERE NOT ABLE TO IMPLANT THEM DUE TO THE THREADS BEING DAMAGED IN THE PRESERVE STEM. PRESERVE STEM WAS EXPLANTED AND THE SURGEON USED A COMPETITOR DEVICE FOR THE HUMERAL SIDE. ALL PARTS AND PIECES WERE REMOVED FROM THE WOUND SITE. THERE

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 22522652 ↗
• InjuryMar 14, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 10 YEARS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT PRESENTED WITH A TSR GLENOID FAILURE/DISLOCATION AND UNDERWENT A FIRST STAGE REVISION. THE SURGEON EXTRACTED ALL COMPONENTS AND PUT A CEMENT SPACER IN SITU. 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: Metal Related Pathology

  MAUDE report 21608411 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 1 MONTH AND 22 DAYS POST THE INITIAL LEFT TSA, THE SUBSCAP REPAIR FAILED AND HAD TO BE FIXED. THE HUMERAL HEAD WAS REMOVED IN ORDER TO DO SO, THEN REPLACED. THE PATIENT WAS REVISED TO EXACTECH DEVICES. 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: Muscle/Tendon Damage

  MAUDE report 20127676 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 16 MONTHS POST INITIAL TSA, THE (B)(6) YEARS OLD FEMALE PATIENT PRESENTED TO THE SURGEON WITH, WHAT APPEARED AS, AN INFECTED, LOOSENING PRIMARY RIGHT TSA. ON XRAY, THE STEM APPEARS LOSE WITH "WINDSHIELD WIPER" EFFECT. HEAD APPEARS IN PLACE ON XRAY. THE PATIENT WAS SCOPED TO TAKE BIOPSIES FOR INFECTION, WHICH WERE NEGATIVE. UPON SCOPING, IT WAS APPARENT THAT REPLICATOR PLATE HAD DISSOCIATED FROM TOP OF THE STEM. THERE WAS ALSO OBVIOUS METALLOSIS. SHOULDER JOINT WAS DEBRIDED WITH SHAVER AND BIOPSIES WERE TAKEN. SHOULDER HAS NOT YET BEEN REVISED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE SURGERY ON THE RIGHT SHOULDER WAS COMPLETED ON (B)(6) 2020. UPON OPENING THE SHOULDER, THE HEAD HAD NOT DISSOCIATED FROM THE STEM. IT TURNS OUT THE STEM WAS LOOSE DUE TO AN INFECTION. THE DEVICES WILL NOT RETURN, THE PATIENT ASKED FOR THE DEVICES. PATIENT IS OK EXCEPT FOR THE INFECTION FOUND IN THE PROCEDURE.

  Patient problems: Bacterial Infection

  MAUDE report 9890528 ↗
• InjuryJul 30, 2019Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT ABOUT 18 MONTHS AGO, THIS FEMALE PATIENT RECEIVED A RIGHT TOTAL SHOULDER PROSTHESIS. THE PATIENT PRESENTED AT THE PHYSICIAN¿S OFFICE WITH A PAINFUL TOTAL SHOULDER AND NO SIGN OF INFECTION. UPON REVIEW OF X-RAY, IT WAS DETERMINED THE HUMERAL HEAD (SIZE 44 SHORT) WAS OVERSTUFFING THE JOINT. LAB WORK CONFIRMED THERE WAS NO SIGNS OF INFECTION. THE SURGEON¿S PLAN WAS TO REVISE BY DOWNSIZING THE HEAD TO A 38MM SHORT. REPORTEDLY, THERE WERE NO COMPLICATIONS AND THE PATIENT WAS STABLE LEAVING OR. THE REMOVED DEVICES ARE NOT BEING RETURNED TO THE MANUFACTURER PER HOSPITAL PROTOCOL. NO FURTHER INFORMATION AVAILABLE IS AT THIS TIME.

  Patient problems: Arthralgia

  MAUDE report 8841337 ↗
• InjuryJun 3, 2019Appropriate Device Problem Term/Code Not Available

  PRIMARY SURGERY: (B)(6) 2018. REVISION DUE TO OSTEOARTHRITIC CHANGES OF THE SHOULDER. PATIENT HAS SIGNIFICANT DEFORMITY.

  Patient problems: No Code Available

  MAUDE report 8662695 ↗
• InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem

  PENDING REVISION DUE TO INFECTION. THE PATIENT DID NOT FINISH THEIR COURSE OF ANTIBIOTICS AND IS INFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 8478043 ↗

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-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-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-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