Equinoxe 314-13-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862196163), received between Apr 21, 2020 and Jun 9, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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 18, 2026.

Recalls naming this device

1. Mar 6, 2024Class IIOpen, 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-1414-2024 · 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.

• InjuryJun 9, 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 LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. PATIENT BEGAN HAVING PAIN IN (B)(6) 2022 WITH NO INJURY. AS A RESULT, APPROXIMATELY 4 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT A LEFT SHOULDER REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 22170886 ↗
• InjuryJun 4, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 9 MONTHS AND 22 DAYS POST THE INITIAL STEMLESS ANATOMIC TOTAL SHOULDER ARTHROPLASTY, THE PATIENT'S ROTATOR CUFF FAILED AND WAS REVISED TO A REVERSE TOTAL SHOULDER ARTHROPLASTY. 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 22144031 ↗
• InjuryAug 22, 2024Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 74 YO FEMALE PATIENT, WHO HAD AN INITIAL LEFT TOTAL SHOULDER REPLACEMENT AND LEFT SHOULDER BICEPS TENODESIS IN (B)(6) 2019, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 4 YEARS 9 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED IN (B)(6) 2024 REPORTING SHE HAD STARTED TO DEVELOP PAIN OVER THE PAST YEAR WHICH HAD WORSENED IN THE PAST MONTH. XR OF THE LEFT SHOULDER DEMONSTRATED SUPERIOR MIGRATION OF THE HUMERAL HEAD WITH POSSIBLE LOOSENING OF THE GLENOID IMPLANT. CT SCAN SHOWED LOOSENING OF THE GLENOID AND ROTATOR CUFF DYSFUNCTION. LABS DONE OF THE ASPIRATIONS OF THE JOINT SHOWED ELEVATED WBCS AT AROUND 7K, ALBEIT WITHOUT ANY ELEVATION OF THE PERCENTAGE OF POLYS. THE CX DID GROW C ACNES. C ACNES IS A WELL-KNOWN CAUSE OF SHOULDER PJI AND CAN PRESENT, AMONG OTHER WAYS, WITH HARDWARE FAILURE IN THE ABSENCE OF ANY FRANK SIGNS/SYMPTOMS OF INFECTION. HOWEVER, IT IS ALSO WELL-KNOWN TO BE RECOVERED AS A CONTAMINANT FROM ORTHOPEDIC JOINT ASPIRATION CXS. THEREFORE, EVEN THOUGH THE CULTURE GREW C ACNES, IT IS DIFFICULT TO BE CONFIDENT THAT THERE IS AN ACTUAL INFECTION PRESENT - GIVEN THE EQUIVOCAL FINDINGS ON THE CELL COUNT. BUT SINCE THE PATIENT W

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Medical device site infection; Metal Related Pathology; Muscle Weakness/Atrophy; Muscle/Tendon Damage; Osteolysis; Pain

  MAUDE report 20033416 ↗
• InjuryApr 30, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 64-YEAR-OLD WHITE FEMALE HAD A LEFT TSA ON (B)(6) 2021. THE PATIENT PRESENTED WITH ASEPTIC GLENOID LOOSENING ON (B)(6) 2023. THE PATIENT UNDERWENT A STANDARD TOTAL REVISION SURGERY ON (B)(6) 2024 IN WHICH THE PATIENT WAS REVISED TO EXACTECH HYBRID RTSA AND THE OUTCOME IS CONSIDERED RESOLVED. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Pain

  MAUDE report 19218176 ↗
• InjuryOct 13, 2023Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2019. THE PATIENT PRESENTED IN (B)(6) 2023 AND HAD TSA GLENOID SHEAR FAILURE NOTED ON IMAGING WITH GRADUALLY INCREASING PAIN OVER THE LAST FEW MONTHS - DATE OF ONSET UNK. THE PATIENT WAS REVISED ON (B)(6) 2023. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICE, POSSIBLY RELATED TO PROCEDURE. OUTCOME: RESOLVED ON (B)(6) 2023.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17929341 ↗
• InjuryApr 18, 2023Fracture; Fracture

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2019. THE PATIENT WAS REVISED ON (B)(6) 2023. IT APPEARS AS THOUGH THE GLENOID FAILED. IT LOOKS LIKE THE POLY SHEARED OFF AT THE CENTER PEG JUNCTION. THE PATIENT WAS CONVERTED TO A REVERSE SHOULDER. 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: Failure of Implant; Insufficient Information

  MAUDE report 16766277 ↗
• InjuryMar 7, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 2.2 YEARS POST INITIAL LEFT SIDE TSA, THE 51 Y/O FEMALE PATIENT PRESENTED BACK TO SURGEON'S OFFICE WITH COMPLAINTS OF THEIR LEFT PRIMARY SHOULDER PAIN. THE PATIENT UNDERWENT GLENOID REVISION SURGERY DUE TO GLENOID FAILURE. DURING THE SURGERY, THE HUMERAL HEAD AND REPLICATOR IMPLANT WERE REMOVED FROM THE PLATFORM STEM. THE GLENOID WAS EXAMINED AND SHOWED TO BE DEFORMED AND MISSING SOME POLY PORTION POSTERIORLY ON THE IMPLANT. THE SURGEON REMOVED THE CAGE GLENOID IMPLANT AND RE-IMPLANTED A NEW EQUINOXE CAGE GLENOID IMPLANT. A NEW REPLICATOR PLATE, SCREW KIT, AND HUMERAL HEAD WERE REPLACED ON THE PRIMARY PLATFORM STEM ALSO. THE PATIENT WAS CLOSED AND LEFT THE OPERATION ROOM (OR) STABLE. ALL FRAGMENTS, PARTS OR PIECES WERE REMOVED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS THE DEVICES WERE DISCARDED. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 16495583 ↗
• InjuryJan 25, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 3 YEARS POST OP THE INITIAL LEFT TSA, THIS (B)(6) FEMALE PATIENT'S WAS REVISED DUE TO ASEPTIC GLENOID LOOSENING. PATIENT HAD A SUBSCAP FAILURE AND A LOOSE TSA GLENOID IN STEMLESS IMPLANT. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND/OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Failure of Implant

  MAUDE report 13341919 ↗
• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 2 MONTHS POSTOP THE INITIAL R TSA THIS (B)(6) Y/O FEMALE PATIENT HAD EARLY INSTABILITY FOLLOWING A ANATOMIC SHOULDER. SHE HAD AN ANTEVERTED GLENOID AND AN AUGMENT WAS USED TO CORRECT THIS ORIGINALLY. DECISION WAS MADE TO CONVERT TO A REVERSE. UPON REVISION SUBSCAP WAS SOLID AND ALL COMPONENTS APPEARED SOLIDLY FIXED. STEM WAS RETAINED. REASON FOR INSTABILITY IS UNKNOWN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. FACILITY POLICY DOE NOT ALLOW DEVICES TO BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 12933364 ↗
• InjuryApr 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 2 YEARS POSTOP THE INITIAL LEFT TSA, THE (B)(6) Y/O FEMALE PATIENT COMPLAINED OF PAIN AND WEAKNESS. AN ARTHROSCOPY WAS COMPLETED TO INVESTIGATE AND SAW THAT THE GLENOID POLY WAS LOOSE IN THE JOINT. DURING A REVISION, THE HUMERUS WAS MOVED OUT OF THE WAY AND THE POLY CAME OUT AT THE SAME TIME. THE CENTER PEG DISLODGED OFF THE PROTHESIS AND STAYED WITHIN THE GLENOID VAULT. PERIPHERAL PEGS STILL INTACT. THE POLY WAS SENT TO PATHOLOGY FOR FURTHER INVESTIGATIONS /INFECTION AS WELL AS THE HUMERAL HEAD. HUMERAL HEAD PROSTHESIS WAS REPLACED, ANATOMIC SHOULDER WAS CONVERTED TO A HEMI AND AFTER THE INVESTIGATIONS ARE COMPLETE, IT WILL BE CONVERTED TO A REVERSE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT RETURN, SENT TO LABORATORY AFTER THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 9981409 ↗

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-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-1415-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Numbe
• 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-0460-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
• Z-0459-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
• 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
• 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