Equinoxe 314-13-32 (UDI 10885862201003)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862201003), received between Aug 25, 2022 and Dec 15, 2025 — classified as 10 injuries.

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

1 FDA recall record name this device's identifier, 1 still open.

7 other recalls cover devices cleared under the same FDA submission (K113309); 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.

Recalls naming this device

1. Mar 6, 2024Open, Classified

   The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

   Z-1415-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 6 YEARS AND 11 MONTHS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO A FAILED/LOOSE GLENOID COMPONENT AND SEVERE GLENOID OSTEOLYSIS. EVERYTHING WAS REMOVED. 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: Aseptic loosening; Osteolysis

  MAUDE report 23801648 ↗
• InjuryMar 24, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4 YEARS AND 3 MONTHS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT PRESENTED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN AND DISSATISFACTION. THE PATIENT WAS SCHEDULED FOR A REVISION OF THE PRIMARY SHOULDER TO A REVERSE TOTAL SHOULDER ARTHROPLASTY. THE PRIMARY GLENOID IMPLANT WAS WORN SUPERIORLY. THE PATIENT UNDERWENT A REVISION PRIMARY TOTAL SHOULDER ARTHROPLASTY TO A REVERSE USING THE CENTRAL SCREW BASEPLATE, 36MM GLENOSPHERE, AND +0 TRAY/LINER. THERE WAS A SURGICAL DELAY/PROLONGATION OF 5-15 MINUTES: IT TOOK EXTRA TIME TO USE A PENCIL TIP BURR FOR REMOVING THE CAGE IMPLANT FROM THE GLENOID. IT TOOK EXTRA TIME AT THE END OF THE PROCEDURE TO RELOCATE THE SHOULDER DUE TO TIGHTNESS. THE SURGEON PERFORMED RELEASES AND CHANGED FROM A +0 CONSTRAINED IMPLANT TO A +0 NON-CONSTRAINED IMPLANT. THERE WAS NO REPORTED BREAKAGE OF A DEVICE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain

  MAUDE report 21677087 ↗
• InjuryMar 18, 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. SUBSEQUENTLY, THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. THE PATIENT HAD MASSIVE TRC TEAR LEADING TO ASEPTIC GLENOID LOOSENING. AS A RESULT, APPROXIMATELY 6 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 21635011 ↗
• InjuryApr 29, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS FEMALE PATIENT'S RIGHT SHOULDER WAS REVISED 5 YEARS 10 MONTHS POST OP INITIAL SURGERY. SURGEON VOICED HIS CONCERNS ABOUT THE GLENOID TO (B)(6) AFTER A ANATOMIC TO REVERSE REVISION SURGERY AND AFTER HE FOUND OUT ABOUT A RECALL. GLENOID WAS REVISED TO COMPETITORS DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING, HOSPITAL KEPT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19203914 ↗
• InjuryOct 30, 2023Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A 58 YO FEMALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2021, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 1 YEAR 2 MONTHS POST THE INITIAL PROCEDURE. FOLLOWING HER REPLACEMENT SURGERY, THE PATIENT BEGAN TO EXPERIENCE INCREASING PAIN AND DECREASED FUNCTION OF HER SHOULDER. AFTER X-RAYS CONFIRMING LOOSENING OF THE GLENOID COMPONENT, THE PATIENT WAS RECOMMENDED TO UNDERGO A REVISION SURGERY, WHICH OCCURRED. NO DEVICE RETURNS ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

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

  MAUDE report 18032174 ↗
• InjuryJun 21, 2023Adverse 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 AN INITIAL RIGHT SHOULDER PROCEDURE ON (B)(6) 2020, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 1 YEAR 6 MONTHS POST THE INITIAL PROCEDURE. HER GLENOID COMPONENT FAILED DUE TO POOR BONE QUALITY, ¿SHE HAD BEEN RADIATED AND HAD POOR GENERAL HEALTH. NO FURTHER INFORMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17172535 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA LEGAL NOTIFICATION, THE PATIENT HAD AN INITIAL RIGHT TSA WITH CAPSULAR RELEASE ON (B)(6) 2019. IN MAY 2021 THE PATIENT HAD INCREASING PAIN AND LOST ALL FUNCTIONAL USE OF HER RIGHT ARM. RADIOGRAPHS WERE CONSISTENT WITH A CATASTROPHIC FAILURE OF THE GLENOID COMPONENT WITH SEVERE GLENOID BONE LOSS, LEFT SHOULDER PAIN, AND PARTIAL THICKNESS ROTATOR CUFF TEAR. THE DECISION WAS MADE TO PROCEED WITH A REVISION. ON OR ABOUT (B)(6) 2021, THE SURGEON PERFORMED THE FIRST OF A TWO-STAGE PROCEDURE WITH A CUSTOM GLENOID IMPLANT. THE SURGEON PERFORMED A RIGHT SHOULDER REMOVAL OF THE LOOSE GLENOID COMPONENT, RIGHT SHOULDER REMOVAL OF THE WELL-FIXED CENTRAL GLENOID CAGE, RIGHT SHOULDER SYNOVIAL BIOPSY, RIGHT SHOULDER EXTENSIVE DEBRIDEMENT AND RESECTION OF METALLOSIS, RIGHT SHOULDER REMOVAL OF LOOSE PERIPHERAL PEGS, RIGHT SHOULDER BONE GRAFTING TO THE GLENOID AND PROXIMAL HUMERUS, AND RIGHT SHOULDER REVISION OF THE HUMERAL COMPONENT WITH EXCHANGE OF THE REPLICATOR PLATE AND HUMERAL HEAD. THE PRE AND POST-OP DIAGNOSIS INCLUDED RIGHT SHOULDER CATASTROPHIC FAILURE GLENOID PROSTHESIS. ON OR ABOUT (B)(6) 2021, THE SURGEON PERFORMED THE SECOND STAGE OF THE TWO-STAGE PROCEDURE. THE SURGERY

  Patient problems: Failure of Implant

  MAUDE report 16941217 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 60 YO FEMALE, INITIAL RIGHT SHOULDER IMPLANTED (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 3 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. PER THE SURGEON, "THE GLENOID FAILED" AND OCCURRED OVER TIME. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PRODUCT IS NOT RETURNING DUE TO HOSPITAL POLICY. NO FURTHER INFORMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 15789671 ↗
• InjuryOct 26, 2022Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED A FEMALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 3 YEARS 9 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT COMPLAINED OF PAIN. THE SURGEON FINDINGS INDICATED WEAR ON GLENOID. PATIENT LAST KNOWN TO BE IN STABLE CONDITION. THE EXPLANTS ARE NOT AVAILABLE FOR RETURN. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Implant Pain; Pain

  MAUDE report 15675281 ↗
• InjuryAug 25, 2022Misassembled; Misassembled

  IT WAS REPORTED THAT A FEMALE PATIENT, INITIALLY IMPLANTED ON (B)(6) 2018, PRESENTED TO THE CLINIC WITH A PAINFUL RIGHT SHOULDER. X-RAY IMAGING SHOW PEG FAILURE PER THE SURGEON. REVISION SURGERY HAS BEEN RECOMMENDED BUT HAS NOT OCCURRED.

  Patient problems: Pain

  MAUDE report 15294414 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113309. One submission often covers many models, so check the product and lot details in each record.

• Z-1413-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47
• Z-1414-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number
• Z-1412-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 3
• Z-0459-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
• Z-0460-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
• Z-0415-2018 · Aug 31, 2017 · Terminated
  Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of
• Z-0414-2018 · Aug 31, 2017 · Terminated
  Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of t