Equinoxe 314-13-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10885862200983), received between Jan 22, 2020 and Jan 26, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (7 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-1414-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTED THAT THEY EXPERIENCE PAIN AND THAT THE POLYETHYLENE COMPONENT HAS DISASSOCIATED. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 24185525 ↗
• InjuryDec 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A LEFT ANATOMIC SHOULDER REPLACEMENT, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 3 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT CONSULTED THE SURGEON REGARDING SHOULDER INSTABILITY DUE TO A SUBSCAPULARIS REPAIR FAILURE. REVISION SURGERY WAS PLANNED TO CHANGE THE ANATOMIC SHOULDER TO A REVERSE. DURING THE HUMERAL HEAD REMOVAL STEP, THE INSITU HUMERAL STEM CAME OUT. SUBSEQUENTLY A FULL REVISION WAS PERFORMED REPLACING ALL IMPLANTS. THERE WERE NO COMPLICATIONS FOR THE PATIENT. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES 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. DEVICE IMAGES WERE PROVIDED. THE CAGE GLENOID WAS OBSERVED TO BE FRACTURED. TWO OF THE PEGS WERE BROKEN OFF THE MAIN CONSTRUCT. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Joint Laxity; Muscle/Tendon Damage

  MAUDE report 23688930 ↗
• InjuryJun 27, 2025Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TSA. SUBSEQUENTLY, THE PATIENT REPORTED EXPERIENCING PAIN. AS A RESULT, THE PATIENT UNDERWENT THE FIRST STAGE OF A TWO-STAGE LEFT SHOULDER REVISION APPROXIMATELY 6 YEARS AND 6 MONTHS AFTER INITIAL IMPLANTATION. DURING THE PROCEDURE THE GLENOID COMPONENT WAS NOTED TO BE LOOSE AND WORN SIGNIFICANTLY. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 22345952 ↗
• InjuryMay 29, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS PATIENT'S LEFT SHOULDER WAS REVISED APPROXIMATELY 5 YEARS POST INITIAL OPERATION. REVISED FOR FAILED CAGE GLENOID. NO FURTHER INFORMATION PROVIDED AT THIS TIME. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22106461 ↗
• InjuryOct 14, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  APPROXIMATELY 3 MONTH(S) AND 10 DAY(S) POST-OPERATIVE OF A LEFT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED BREAKAGE OF A COMPONENT. PATIENT WOKE UP WITH A POSTERIOR DISLOCATION WHICH SPONTANEOUSLY RELOCATED. DECISION TAKEN TO PERFORM A REVISION. PLASTIC GLENOID PLATE FOUND TO HAVE SHEARED OFF UNDERLYING METAL PINS AND BE FREE FLOATING IN JOINT. IN AN EARLIER REPORTED EVENT, THE PATIENT EXPERIENCED INSTABILITY/SUBLUXATION INTRA-OPERATIVELY AND ONCE SHOULDER LOCATED CORRECTLY, PLACED IN SHOULDER IMMOBILIZER SLING WITH WEDGE FOR 3 WEEKS IN NEUTRAL ROTATION. THE PATIENT UNDERWENT A STANDARD TOTAL WITH STEMLESS REVISION WITH THE REPORTED REMOVAL OF THE GLENOID, STEMLESS HUMERAL HEAD, AND STEMLESS HUMERAL CAGE. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Joint Dislocation

  MAUDE report 20444636 ↗
• InjurySep 9, 2024Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT THIS 61 Y/O MALE PATIENT WAS REVISED APPROXIMATELY 3 YEARS 3 MONTHS POST OP. PATIENT COMPLAINED OF PAIN. POLY SHEERED OFF FROM THE PEGS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: CHAIN OF COMMAND DUE TO RECALL HOSPITAL WILL NOT RELEASE.

  Patient problems: Pain

  MAUDE report 20177415 ↗
• InjuryJul 9, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 1 YEAR(S), 11 MONTH(S) AND 6 DAY(S) POST-OPERATIVE OF A LEFT TSA, THE PATIENT PRESENTED WITH ASEPTIC GLENOID LOOSENING. IT WAS DESCRIBED AS LOOSENING OF GLENOID COMPONENT AND PAINFUL HARDWARE. THE PATIENT UNDERWENT A STANDARD TOTAL WITH PRESERVE STEM REVISION SURGERY. THE OUTCOME OF THIS EVENT IS STILL CONSIDERED CONTINUING. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND DEFINITELY RELATED TO THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 19703752 ↗
• InjuryApr 29, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL SHOULDER REPLACEMENT PROCEDURE ON (B)(6) 2017 AND THEN WAS REVISED ON (B)(6) 2024. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO COMPONENT LOOSENING. BOTH THE HUMERAL STEM AND ANATOMIC CAGE GLENOID COMPONENTS WERE LOOSE. THE COMPONENTS WERE REMOVED AND THE SURGEON IMPLANTED COMPETITOR IMPLANTS. 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: Failure of Implant; Insufficient Information

  MAUDE report 19209072 ↗
• InjuryJan 8, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2017 AND PRESENTED ON 12-NOV-2019 WITH ASEPTIC GLENOID LOOSENING. GLENOID LOOSENING AND HUMERAL BONE LOSS. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. OUTCOME IS RESOLVED BY REVISION ON 18-DEC-2019. SPACER - HUGE BONE LOSS. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY. EBI INITIAL SURGERY ATTACHED.

  Patient problems: Failure of Implant

  MAUDE report 18465133 ↗
• InjuryAug 23, 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 CLINICAL EQUINOXE SHOULDER STUDY, THAT A 66 YO MALE PATIENT, WHO HAD AN INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2018, DEVELOPED WORSENING SHOULDER PAIN W/OUT INCITING AN EVENT ON AN UNKNOWN DATE IN 2022. X-RAYS DEMONSTRATE GLENOID LOOSENING AND OSTEOLYSIS AROUND STEMLESS COMPONENT. THE PATIENT HAD A SUBACROMIAL CORTICOSTEROID INJECTION. RELATIVE REST, ACTIVITY MODIFICATION, AND NSAIDS WERE PRESCRIBED. OUTCOME IS CONTINUING. THE PATIENT IS CONSIDERING REVISION SURGERY. THE STUDY INDICATES THAT THIS IS DEFINITELY NOT RELATED TO THE DEVICES OR THE PROCEDURE. NO FURTHER INFORMATION KNOWN.

  Patient problems: Implant Pain; Loss of Range of Motion; Medical device site infection; Osteolysis; Pain

  MAUDE report 17608067 ↗
• InjurySep 8, 2022Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2020. THE PATIENT HAD A REVISION DUE TO UNKNOWN REASONS AND WAS REVISED TO ZIMMER BIOMET REVERSE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15380007 ↗
• InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 10 MONTHS POSTOP THE INITIAL L TSA, THE (B)(6) Y/O MALE PATIENT WAS EXPERIENCING PAIN AND DISCOMFORT IN L SHOULDER AND WAS CONVERTED FROM AN ANATOMIC TOTAL SHOULDER TO A REVERSE SHOULDER. ALL ANATOMIC COMPONENTS, WITH THE EXCEPTION OF THE HUMERAL STEM, WERE EXPLANTED. THE STEM REMAINED INTACT AND A REVERSE SHOULDER WAS IMPLANTED USING THE CURRENT STEM. PT WAS REVISED TO A 42MM +4 OFFSET GLENOSPHERE, +0 ADAPTER TRAY, SUP/POST AUGMENTED BASEPLATE (LEFT) AND 42MM +0 HUMERAL LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING DUE TO FACILITY POLICY.

  Patient problems: Pain

  MAUDE report 12303196 ↗
• InjuryJan 22, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 2 YEARS POST-OP THE INITIAL TSA FOR THIS (B)(6) FEMALE, THE INITIAL REASON FOR REVISION WAS THOUGHT TO BE CUFF FAILURE BUT ONCE WE OPENED THE PATIENT UP IT WAS APPARENT THE GLENOID WAS LOOSE. THERE HAS BEEN CATASTROPHIC POSTERIOR WEAR OF THE COMPONENT WHICH HAS CREATED AN OSTEOLYTIC RESPONSE AND THEN LOOSENED THE IMPLANT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WILL NOT BE RETURNED PER HOSPITAL POLICY. ALL AVAILABLE INFORMATION HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 9617875 ↗

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-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-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