Equinoxe 314-13-14 (UDI 10885862172716)Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10885862172716), received between Dec 26, 2019 and Oct 27, 2025 — classified as 32 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (15 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-1413-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL PRIMARY TOTAL SHOULDER REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN. AS A RESULT, APPROXIMATELY NINE YEARS AND ELEVEN 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.

  Patient problems: Pain

  MAUDE report 23391600 ↗
• InjuryJul 7, 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 ANATOMIC SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED POSSIBLE ASEPTIC LOOSENING OF THE GLENOID COMPONENT, DISPLACED POLY. AS A RESULT, APPROXIMATELY FIVE YEARS AND ELEVEN MONTHS POST-SURGERY, DIAGNOSTIC IMAGING TO CONFIRM LOOSENING WAS ORDERED. THIS EVENT IS CONSIDERED CONTINUING. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aseptic loosening

  MAUDE report 22421649 ↗
• InjuryJun 17, 2025Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED APPROXIMATELY 45 MONTHS AFTER A RIGHT TOTAL SHOULDER ANATOMIC REPLACEMENT; A PATIENT WAS CONVERTED TO A RIGHT TOTAL REVERSE SHOULDER REVISION PROCEDURE. UPON EXPLANT OF THE POLYETHYLENE COMPONENT, PROSTHESIS WEAR WAS APPRECIATED. RADIOGRAPH IMAGES WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO MEDICAL OR SURGICAL PROCEDURES OR DELAYS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Insufficient Information

  MAUDE report 22234173 ↗
• InjuryApr 1, 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 TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. GLENOID COMPONENT PROBLEM MOST CONSISTENT WITH LOOSENING AND POSSIBLY POLYETHYLENE WEAR. AS A RESULT, ALMOST 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: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 21746012 ↗
• InjuryJan 8, 2025Fracture; Fracture

  AS REPORTED BY MEDWATCH REPORT (B)(4), APPROXIMATELY 5 YEARS AND 9 MONTHS POST THE INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT REPORTED WORSENING LEFT SHOULDER PAIN. A CT SCAN REVEALED POST-SURGICAL CHANGES CONCERNING FOR OSTEOLYSIS ABOUT THE GLENOID AND PROXIMAL HUMERAL PROSTHETIC COMPONENTS. IT ALSO DEMONSTRATED A SUPER IMPOSED PATHOLOGIC FRACTURE OF THE GLENOID. THE EXPLANTED DEVICES ARE CURRENTLY IN THE LAB FOR TISSUE EXAM.

  Patient problems: Implant Pain; Osteolysis; Pain

  MAUDE report 21108350 ↗
• InjuryJan 6, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 69 MONTHS AFTER A RIGHT TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT HAS HAS NOT UNDERWENT A REVISION PROCEDURE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Inflammation; Loss of Range of Motion; No Clinical Signs, Symptoms or Conditions; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 21085384 ↗
• InjuryJan 6, 2025Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 71 MONTHS AFTER A RIGHT TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, DISCOMFORT, INFLAMMATION, LIMITED RANGE OF MOTION AND COMPONENT LOOSENING, SOFT TISSUE DAMAGE AND BONE LOSS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Inflammation; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21080381 ↗
• InjuryDec 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THIS PATIENT'S SHOULDER IS EXPERIENCING PAIN AND LOSS OF MOBILITY. PATIENT'S CT SCAN SHOWS ONE OF THE PINS OUT OF ALIGNMENT. NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 20838991 ↗
• InjuryNov 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 4 YEAR(S), 11 MONTH(S) AND 28 DAY(S) POST-OPERATIVE OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING ¿ LOOSENING OF CAGE GLENOID. THE PATIENT UNDERWENT A STANDARD TOTAL REVISION WITH THE REPORTED REMOVAL OF THE REPLICATOR PLATE, TORQUE SCREW, HUMERAL HEAD, AND GLENOID COMPONENTS. THE OUTCOME OF THIS EVENT IS NOW CONSIDERED RESOLVED AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND DEFINITELY RELATED 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 20790896 ↗
• InjuryJul 10, 2024Naturally Worn; Naturally Worn

  APPROXIMATELY 7 YEARS AFTER INITIAL LEFT TSA, THE PATIENT WAS REVISED DUE TO FAILURE OF THE CAGE GLENOID, THE PEGS HAD DISSOCIATED FROM THE POLY. THE PATIENT HAD OSTEOLYSIS, SIGNS OF METALLOSIS AND SIGNIFICANT BONE LOSS. THE PATIENT WAS NOT REVISED TO EXACTECH DEVICES. THE PATIENT WAS REVISED TO A DJO GLENOID AND EXACTECH HUMERAL COMPONENTS. THE EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT DID NO LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS PROVIDED. PRODUCT NOT RETURNING DUE TO HOSPITAL POLICY.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 19716144 ↗
• InjuryJul 2, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 4 YEAR(S), 11 MONTH(S), AND 14 DAY(S) POST-OPERATIVE OF A RIGHT TSA, THE PATIENT PRESENTED WITH ASEPTIC GLENOID LOOSENING FOR ABOUT 1 MONTH WITHOUT INJURY. A JOINT OPERATION AND CT SCAN ARE SCHEDULED, THE EVENT IS CONTINUING, AND THE DEVICE(S) REMAIN IMPLANTED. THE CLINICAL REPORT INDICATES THAT THE EVENT IS DEFINITELY NOT RELATED TO THE DEVICE(S) AND UNLIKELY RELATED TO THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19662545 ↗
• InjuryJun 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 88 MONTHS AFTER A LEFT TOTAL SHOULDER REPLACEMENT PROCEDURE, A PATIENT WAS REVISED DUE TO POLY WEAR AND OSTEOLYSIS. NO BREAKAGE OF DEVICE, NO DELAYS IN SURGERY. 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

  MAUDE report 19611427 ↗
• InjuryApr 24, 2024Crack; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Crack; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE 86 YEAR OLD MALE PATIENT HAD AN INITIAL RIGHT TSA IN (B)(6) 2016 OR (B)(6) 2015. THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO WEAR AND TEAR. THE CAGE GLENOID WAS WORN OUT AND WAS LOOSE IN THE JOINT WITH ONLY THE CAGE LEFT, WHICH WAS SAFELY REMOVED. THE POLY IMPLANT WAS CRACKED AND HAD A SIGNIFICANT AMOUNT OF CEMENT NEARLY COVERING THE BACK OF THE IMPLANT. NO FRAGMENTS, PARTS OR PIECES FELL INTO THE PATIENT. IMPLANT AND PEGS ALL REMOVED. THERE WAS NO REPORTED 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 19177888 ↗
• InjuryFeb 28, 2024Migration or Expulsion of Device; Naturally Worn; Migration; Migration or Expulsion of Device; Naturally Worn; Migration

  IT WAS REPORTED THAT A PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6)2014, UNDERWENT A REVISION PROCEDURE ON (B)(6)2024, APPROXIMATELY 9 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH COMPLAINTS OF PAIN. THE GLENOID COMPONENT HAD MIGRATED FROM ITS ORIGINAL POSITION. SIGNIFICANT WEAR AND OSTEOLYSIS FOUND. BONE GRAFTING AND CONVERSION TO REVERSE WAS PERFORMED. THERE WERE NO ISSUES WITH THE SURGERY. X-RAYS WERE PROVIDED. EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Osteolysis; Pain

  MAUDE report 18803637 ↗
• InjuryJan 11, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY TWO YEARS POST INITIAL RIGHT TSA, THE 67 Y/O PATIENT EXPERIENCED CAGE LINER DISSOCIATED. PATIENT HAD A REVISION ON (B)(6)2024. PER CLINICAL STUDY REPORT THE REPORTED EVENT IS DEFINITELY RELATED TO THE DEVICE AND THE PROCEDURE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18499028 ↗
• InjuryNov 16, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY ONE YEAR POST INITIAL LEFT TSA, THE 64 Y/O MALE PATIENT EXPERIENCED PAINFUL TOTAL SHOULDER WITH RTC TENDONITIS. PATIENT HAD LIMITATIONS IN MOTION AND PERSISTENT PAIN. PATIENT WAS REVISED AND EVERYTHING WAS REMOVED EXCEPT THE PRESERVE STEM. PUT IN AN REVERSE EXTENDED BASEPLATE STANDARD SIZE AND HUMERAL LINER WAS IMPLANTED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN X-RAYS OR IMAGES. THE DEVICES WILL BE RETURN.

  Patient problems: Implant Pain; Loss of Range of Motion; Pain

  MAUDE report 18148217 ↗
• InjuryOct 26, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT, INITIAL SHOULDER IMPLANTED ON (B)(6) 2016, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 7 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT HAD PRESENTED WITH PAIN. THE GLENOID COMPONENT WAS STABLE BUT WAS REMOVED EASILY EXCEPT THE CENTRAL CAGE REMAINED IN THE BONE. A TREPHINE REAMER AND THREAD IN EXTRACTOR WERE USED TO REMOVE THE GLENOID. SIGNIFICANT WEAR OF THE GLENOID WAS VISUALLY CONFIRMED PRIOR TO ITS REMOVAL. THE STEM WAS PLANNED TO BE KEPT, BUT WAS FOUND TO BE LOOSE, SO REMOVAL WAS PERFORMED AND A CONVERSION TO A COMPETITOR¿S COMPONENTS WAS DONE WITH SIGNIFICANT BONE GRAFTING ON GLENOID. THERE WERE NO ISSUES WITH THE SURGERY. X-RAYS AND DEVICE IMAGES PROVIDED. EXPLANTS ARE NOT AVAILABLE FOR RETURN. REASON UNKNOWN. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 18012426 ↗
• InjuryJul 20, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6)2014. THE PATIENT WAS REVISED ON (B)(6)2023 DUE TO SHOULDER PAIN. THE SURGEON FOUND INFLAMMATION AND SCAR TISSUE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. NO SURGERY DELAY.

  Patient problems: Failure of Implant; Inflammation; Pain; Scar Tissue

  MAUDE report 17365922 ↗
• InjuryJun 21, 2023Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 58-YEAR-OLD MALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2013, UNDERWENT A REVISION PROCEDURE, AND WAS CONVERTED TO AN RSA ON (B)(6) 2023, APPROXIMATELY 9 YEARS 6 MONTHS POST THE INITIAL PROCEDURE. THE SURGEON HAD TO REVISE THE GLENOID DUE TO LOOSENING AND WEAR. DEVICE BREAKAGE WAS INDICATED, BUT NO PARTS OR PIECES FELL INTO THE PATIENT. ALL FRAGMENTS WERE REMOVED. THERE WERE NO SURGICAL DELAYS REPORTED. NO PATIENT HISTORY, COMORBIDITIES, OR X-RAYS WERE ABLE TO BE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS AVAILABLE FOR RETURN.

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

  MAUDE report 17171087 ↗
• InjuryApr 21, 2023Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 9.3 YEARS POST INITIAL RIGHT TSA, THE MALE PATIENT HAD A REVISION DUE TO WEAR AND OSTEOLYSIS. A COMPETITOR¿S REVERSE GLENOID WAS USED WITH FRESH FEMORAL HEAD BONE GRAFTING. THE EXACTECH STEM WAS ATTEMPTED TO BE KEPT BUT IT WAS TOO TIGHT, SO IT WAS THEN REMOVED AND CONVERTED TO A COMPETITOR¿S STEM BROACHED LOWER INTO THE HUMERUS FOR SPACE. NO COMPLICATIONS WERE NOTED. EXPLANTS NOT AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Implant Pain; Muscle/Tendon Damage; Osteolysis

  MAUDE report 16785896 ↗
• InjuryAug 23, 2022Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  AS REPORTED, APPROXIMATELY 3 YEARS POST OP THE INITIAL RIGHT TSA, THIS FEMALE PATIENT WAS REVISED DUE TO SIGNIFICANT METALOSIS WITH HUMERAL HEAD SCRATCHING AGAINST CENTRAL CAGE OF GLENOID. THE PERIPHERAL PEGS WERE STILL CONNECTED TO POLY BUT WAS MIGRATED AWAY FROM ORIGINAL POSITION. THE CENTRAL CAGE REMAINED IN ITS ORIGINAL POSITION WELL FIXED. GLENOID WAS BONE GRAFTED AND CONVERTED TO ARTHREX BASEPLATE AND GLENOSPHERE. THE HUMERAL HEAD AND REPLICATOR WERE REMOVED. A +0 TRAY AND 36 +0 LINER WAS IMPLANTED WITH GOOD STABILITY AND ROM. PATIENT LAST KNOWN TO BE IN STABLE CONDITION. EXPLANTS NOT AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Failure of Implant; Pain

  MAUDE report 15277721 ↗
• InjuryApr 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING REMOVAL, THE SURGEON FOUND THE PATIENT LEFT SHOULDER IMPLANT TO BE DAMAGED. THE GLENOID WAS MISSING A CHUNK. SURGEON ONLY REMOVED THE GLENOID FROM THE PATIENT. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL NOT BE RETUNING, SURGEON KEPT IMPLANT.

  Patient problems: Failure of Implant

  MAUDE report 14082956 ↗
• InjuryNov 30, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 8 YRS POST AN ANATOMIC TSA, THIS 56 Y/O MALE PATIENT HAD AN ANATOMIC REVISION DUE TO GLENOID LOOSENING. DEFECT WAS BONE GRAFTED AND IMPLANTED BACK TO A STABLE SURFACE.

  Patient problems: Failure of Implant

  MAUDE report 12900381 ↗
• InjurySep 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, APPROXIMATELY 4 YRS POSTOP THE INITIAL RIGHT TSA, THIS 63 Y/O MALE PATIENT¿S SHOULDER WAS REVISED. THE CAGE HAD SEPARATED FROM THE POLY. HE REMOVED THE HEAD, REPLICATOR PLATE, SCREW, AND THE GLENOID. STEM STAYED. HE GRAFTED THE GLENOID AND LEFT IT. HE THEN REPLACED THE PLATE AND HEAD, LEAVING IT A HEMI. NO BROKEN PARTS WERE LEFT BEHIND. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETURNING, REP WAS NOT ABLE TO RETRIEVE THEM.

  Patient problems: Failure of Implant

  MAUDE report 12405960 ↗
• InjuryAug 12, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 2.5 YR POSTOP THE INITIAL RTSA, THE MALE PATIENT HAD THE RIGHT LOOSE GLENOID COMPONENT REMOVED ALONG WITH THE HUMERAL HEAD AND REPLICATOR PLATE TO GET TO THE GLENOID. BONE GRAFT WAS USED TO FILL HOLES ON THE GLENOID. THE SURGEON ALSO USED A NEW REPLICATOR PLATE AND HEAD AND LEFT THE SHOULDER AS A HEMI. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT RETURN DUE TO FACILITY POLICY.

  Patient problems: Failure of Implant

  MAUDE report 12312951 ↗

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-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-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-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-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