Equinoxe 314-13-34Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10885862201027), received between Sep 13, 2019 and Sep 1, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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-1415-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Fracture

  It was reported that the patient underwent an initial left total shoulder arthroplasty. Subsequently, it was reported that the patient experienced erosion and prosthesis fracture. As a result, the patient will require surgical intervention on a future date. No further patient impact reported. No further information available.

  Patient problems: Erosion

  MAUDE report 50544602 ↗
• InjuryJun 3, 2026Naturally Worn

  IT WAS REPORTED THAT A PATIENT, WHO HAD A RIGHT TSA, UNDERWENT A REVISION PROCEDURE. THE PATIENT PRESENTED WITH COMPLAINTS OF PAIN. THE SURGEON SCOPED THE SHOULDER AND OBSERVED THE POLY SHOWED WEAR AND DETERMINED THE BEST COURSE OF ACTION WAS TO CONVERT THE PATIENT FROM AN ANATOMICAL TO A REVERSE SHOULDER USING A CENTRAL SCREW BASEPLATE. THE ANATOMICAL COMPONENTS WERE EXPLANTED, AND A REVERSE TOTAL WAS IMPLANTED. 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 AVAILABLE FOR RETURN. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 25383083 ↗
• InjuryJul 30, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT A 70 YO MALE PATIENT, WHO HAD THEIR RIGHT SHOULDER IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 6 YEARS 1 MONTH POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO FAILURE OF THE ANATOMIC GLENOID. THE PATIENT HAD SEVERE LYSIS AS A RESULT OF THE GLENOID POLYETHENE WEAR. THEY WERE CONVERTED TO A CTA HEAD IMPLANT AS THERE WAS NOT ENOUGH BONE STOCK FOR A REVERSE GLENOID IMPLANT. 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-RAY IMAGES WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISPOSED OF BY THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Osteolysis

  MAUDE report 22671527 ↗
• InjuryJul 7, 2025Fracture; Detachment of Device or Device Component; Naturally Worn; Fracture; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ANATOMIC SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN SECONDARY TO POLY DISASSOCIATION. AS A RESULT, APPROXIMATELY SEVEN YEARS AND SEVEN MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 2 FOR THIS EVENT/PATIENT.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 22420891 ↗
• InjuryApr 1, 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. IT WAS ALSO NOTED BY THE PATIENT THAT THEY MOVED ARM AWKWARDLY IN (B)(6) 2024 AND HAD INCREASED PAIN. AS A RESULT, A REVISION IS TO BE SCHEDULED FOR THE PATIENT. NO FURTHER IMPACT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21741848 ↗
• InjuryJan 2, 2025Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 60 MONTHS AFTER A LEFT TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, DISCOMFORT, INFLAMMATION, IMPAIRED RANGE OF MOTION; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE AND BONE LOSS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Discomfort; Inflammation; Joint Laxity; Loss of Range of Motion; Muscle/Tendon Damage; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 21054409 ↗
• InjuryDec 30, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 61 MONTHS AFTER A RIGHT TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, DISCOMFORT AND INFLAMMATION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Discomfort; Inflammation; Loss of Range of Motion; Muscle/Tendon Damage; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 21034295 ↗
• InjuryDec 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 68 MONTHS AFTER A RIGHT TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20837067 ↗
• InjuryNov 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  POST-OPERATIVE OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. IT WAS FURTHER STATED HYBRID GLENOID WITH LOOSENING. PEG DISPLACEMENT. NO ACTIONS WERE TAKEN AT THE TIME OF THE REPORTED EVENT AND THE OUTCOME REMAINS CONTINUING. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20665354 ↗
• InjuryNov 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 7 YEAR(S) AND 1 DAY(S) POST-OPERATIVE OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. PATIENT BEGAN HAVING PAIN AND NUMBNESS WITHOUT INJURY. THE PATIENT WAS ADMINISTERED MEDICATION, AND THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Numbness; Pain

  MAUDE report 20665250 ↗
• InjuryAug 2, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA EXPERIENCE REPORT THAT "THE PATIENT WAS REVISED DUE TO INFECTION." THE RIGHT SIDE WAS AFFECTED. ALL IMPLANTS WERE REMOVED. THERE WAS NO REPORTED SURGICAL DELAY. INITIAL IMPLANT DATE: (B)(6) 2023. REVISED ON (B)(6) 2024.PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.UNABLE TO OBTAIN IMAGES OR X-RAYS. PRODUCT NOT RETURNING: DISPOSED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19893068 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2016. THE PATIENT WAS REVISED ON (B)(6) 2024; REASON NOT REPORTED. THE PATIENT WAS REVISED TO AN HRP WITH A +10 EXT CAGE BASEPLATE WITH A FEMORAL HEAD STRUCTURAL ALLOGRAFT. 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 19264127 ↗
• InjuryAug 28, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A MALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2020, UNDERWENT A STAGE 1 REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 3 YEARS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO POST-TRAUMATIC INSTABILITY WHICH WAS DEVELOPED DUE TO A RUPTURE OF THE PCR. AFTER OPENING THE SHOULDER, THE POLY WAS FOUND DISASSOCIATED FROM THE PEGS OF THE CAGE GLENOID. EVERYTHING WAS REMOVED AND A CEMENT SPACER WAS INSERTED. 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 DEVICE IMAGES OR X-RAYS WERE AVAILABLE. THE DEVICES ARE NOT AVAILABLE FOR RETURN AS THE HOSPITAL DISPOSED OF THEM. NO FURTHER INFORMATION.

  Patient problems: Joint Laxity; Rupture

  MAUDE report 17634266 ↗
• InjuryFeb 6, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THIS FEMALE PATIENT UNDERWENT A RIGHT TOTAL SHOULDER REVISION TO CONVERT FROM A TSA TO A REVERSE TSA DUE TO GLENOID IMPLANT FAILURE. AFTER ASSESSMENT SURGEON WAS ABLE TO DETERMINE THAT THE ROTATOR CUFF AND SUBSCAP WERE INTACT AND THAT REVISION WAS NEEDED DUE TO IMPLANT FAILURE. THE CENTRAL CAGE ON THE CAGE GLENOID REMAINED IN THE VAULT AND THE GLENOID IMPLANT ALONG WITH THE 3 PERIPHERAL PEGS WAS DISLODGED FROM GLENOID. A REVISION WAS PERFORMED AND SUCCESSFULLY CONVERTED THE TOTAL SHOULDER TO A REVERSE TOTAL SHOULDER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16302992 ↗
• InjuryJun 8, 2022Break; Break

  SURGEON USED A CAGED AUGMENTED GLENOID IN HIS CASE. THEY FOLLOWED THE SURGICAL STEPS AND THEN TRIED TO IMPLANT THE GLENOID. THE (B)(6) PATIENT'S BONE WAS VERY HARD AND THEY WERE UNABLE TO SEAT THE IMPLANT. THE SURGEON THEN TRIED TO REMOVE THE IMPLANT BUT TWO OF THE METAL PIECES DISENGAGED AND STAYED IN THE GLENOID. IT WAS VERY DIFFICULT TO REMOVE THE TWO PARTS. THEY THEN IMPLANTED A ALL POLY ONE TO COMPLETE THE CASE. THERE WAS A 5-15 MINS SURGICAL DELAY/PROLONGATION, NO ADVERSE EVENTS AS A RESULT OF THE DELAY PROLONGATION. THE PATIENT HAD NO ADVERSE AFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14631649 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 7 MOS POSTOP THE INITIAL RIGHT SHOULDER TSA, THIS (B)(6) Y/O MALE PATIENT WAS REVISED DUE TO SEPTIC LOOSENING. THE PATIENT HAS HAD DEEP CONTINUOUS PAIN SINCE RIGHT SHOULDER SURGERY BUT IT HAS PROGRESSIVELY GOTTEN WORSE OVER THE LAST FEW MONTHS. PATIENT HAS TESTING AND ASPIRATION. THE CASE REPORT FORM INDICATES THIS EVENT IS NOT RELATED TO DEVICES AND DEFINITELY RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Bacterial Infection

  MAUDE report 12830108 ↗
• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 6 YRS POSTOP THE INITIAL TSA, THIS MALE PATIENT WAS DOING WELL AND DECIDED TO SHOVEL SNOW. DURING SNOW SHOVELING HE EXPERIENCED A PAINFUL INCIDENT AND WENT TO DOCTOR. HE WAS EVALUATED AND A RIGHT SHOULDER SCOPE WAS PERFORMED. AFTER THIS TREATMENT FAILED, HE RETURNED FOR A REVISION AND CONVERSION TO A REVERSE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WILL NOT RETURN DUE TO HOSPITAL POLICY.

  Patient problems: Failure of Implant

  MAUDE report 12505193 ↗
• InjurySep 13, 2019Device Slipped

  IT WAS REPORTED THAT A MALE PATIENT RECEIVED A RIGHT SHOULDER ARTHROPLASTY ON (B)(6) 2019. PATIENT WAS THEN REVISED DUE TO INSTABILITY/SUBLUXATION.

  Patient problems: No Code Available

  MAUDE report 9034124 ↗

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-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-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-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