Equinoxe 314-13-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10885862172679), received between Feb 19, 2021 and Aug 31, 2026 — classified as 37 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (18 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-1412-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Loosening of Implant Not Related to Bone-Ingrowth

  As reported by the Equinoxe Shoulder Study, approximately 3 years and 5 months post the initial right total shoulder arthroplasty, the patient was revised due to a loose failed poly liner and cuff failure. No further information provided.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 50529903 ↗
• InjuryDec 22, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND METALLOSIS. AS A RESULT, THE GLENOID SNAPPED IN HALF AND THE PATIENT WAS REVISED TO A COMPETITOR'S DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 23866794 ↗
• MalfunctionSep 10, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER ARTHROPLASTY ON THE LEFT SIDE. SUBSEQUENTLY, APPROXIMATELY 3 YEARS POST-OP, THE WAS EXPERIENCING PAIN, DECREASE IN MOTION, AND CLICKING. IT WAS NOTED THAT THERE WAS POLYETHYLENE WEAR WITH OR WITHOUT OSTEOLYSIS. A REVISION WAS SCHEDULED, BUT INFORMATION HAS NOT BEEN RECEIVED TO INDICATE IF IT WAS PERFORMED. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 23016925 ↗
• InjuryJul 28, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, APPROXIMATELY 11 YEARS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO A FAILED CAGE GLENOID, WHERE THE POLY COMPLETELY ERODED AND ONE OF THE PEGS HAD BECOME LOOSE. THE SURGEON WAS ABLE TO FULLY DEBRIDE ALL CAGE GLENOID FRAGMENTS FROM THE PATIENT. THE GLENOID WAS REVISED TO A COMPETITOR IMPLANT. THE SURGEON REVISED TO AN EXACTECH 9MM HUMERAL STEM, +0MM HUMERAL TRAY, +2.5 - 36MM HUMERAL LINER, AND A REVERSE TORQUE DEFINING SCREW. THERE WAS A > 45 MINUTE DELAY TO SURGERY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22629666 ↗
• InjuryJun 23, 2025Fracture; Naturally Worn; Migration; Fracture; Naturally Worn; Migration

  IT WAS REPORTED THAT A 70 YO FEMALE PATIENT, WHO HAD A PRIMARY RTSA IMPLANTED, UNDERWENT A REVISION PROCEDURE. THE PATIENT NOTICED ISSUES WITH MOTION. XRAYS WERE TAKEN AND SHOWED SUPERIOR SHIFT AND THE STEM IN VALGUS CAUSING SOME MEDIAL RESORPTION ON HUMERUS. THE SURGEON REVISED THE CAGE GLENOID TO A TORNIER BASEPLATE AND 36 GLENOSPHERE. THE STEM WAS WELL FIXED, SO HE LEFT IT IN. THE SURGEON REVISED THE HUMERAL COMPONENTS TO OUR HUMERAL TRAY AND LINER (+0MM HUMERAL ADAPTER TRAY, +2.5MM 36MM HUMERAL LINER, REVERSE TORQUE DEFINING SCREW KIT). THERE WAS A 45 MINUTE SURGICAL DELAY REPORTED WITH NO ADVERSE EVENT TO THE PATIENT. THE REPORT INDICATED THE GLENOID CAGE AND PEGS WERE SEEMINGLY NOT IN PLACE ON THE X-RAYS TAKEN AND THE DELAY WAS DUE TO THE REVISION SURGERY NEEDED. THERE WERE NO DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THE HOSPITAL KEEPS THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Osteolysis

  MAUDE report 22311884 ↗
• InjuryMar 31, 2025Fracture; Detachment of Device or Device Component; Naturally Worn; Fracture; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S LEFT SHOULDER WAS REVISED. THE REVISION WAS DUE TO A FAILED ROTATOR CUFF AND WORN POLYETHYLENE. PATIENT ALSO HAD METALLOSIS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Metal Related Pathology; Muscle/Tendon Damage; Pain

  MAUDE report 21733678 ↗
• InjuryMar 14, 2025Fracture; Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Fracture; Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  AS REPORTED, APPROXIMATELY 10 YEARS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT PRESENTED WITH A TOTAL SHOULDER REPLACEMENT GLENOID FAILURE/DISLOCATION AND UNDERWENT A FIRST STAGE REVISION. THE SURGEON EXTRACTED ALL COMPONENTS AND PUT A CEMENT SPACER IN SITU. 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: Metal Related Pathology

  MAUDE report 21608386 ↗
• InjuryMar 10, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ANATOMIC TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2019. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO SEVERE WEAR AND METALLOSIS ON (B)(6) 2025. NO FURTHER PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Metal Related Pathology

  MAUDE report 21569102 ↗
• InjuryFeb 26, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4.4 YEARS POST THE INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT HAD ALL IMPLANTS EXPLANTED DUE TO STEM LOOSENING. THE PATIENT WAS REVISED TO COMPETITOR DEVICES. THERE WAS NO REPORTED BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21468572 ↗
• InjuryDec 4, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 4 YEAR(S), 9 MONTH(S) AND 7 DAY(S) POST-OPERATIVE OF A LEFT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. PATIENT BEGAN HAVING PAIN WITHOUT INJURY. 1 YEAR AND 4 MONTHS FOLLOWING THE ONSET OF SYMPTOMS, THE PATIENT UNDERWENT A STANDARD TOTAL WITH PRESERVE STEM REVISION WITH THE REPORTED REMOVAL OF THE REPLICATOR PLATE, TORQUE SCREW, HUMERAL HEAD, AND GLENOID. THE OUTCOME OF THIS EVENT IS NOW CONSIDERED RESOLVED AND 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: Inadequate Osseointegration; Pain

  MAUDE report 20847419 ↗
• InjuryJun 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 105 MONTHS AFTER A LEFT TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT HAD A REVISION SURGERY DUE TO CUFF FAILURE. EVERYTHING WAS REMOVED. THE PATIENT WAS REVISED TO EXACTECH DEVICES. NO DELAY IN SURGERY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Muscle/Tendon Damage

  MAUDE report 19591762 ↗
• InjuryJun 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 2 MONTHS AND 2 DAYS POST THE INITIAL ATSA, THE PATIENT WAS REVISED WITH AN ANTIBIOTIC SPACER. THE SPACER WAS REPLACED WITH REVERSE SHOULDER COMPONENTS ON (B)(6) 2016. NO OTHER INFORMATION REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19446265 ↗
• InjuryMay 13, 2024Fracture; Fracture

  AS REPORTED, APPROXIMATELY 3 YEARS AFTER THE INITIAL LEFT TSA, THE 68 YEAR OLD FEMALE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO INCREASED PAIN IN HER SHOULDER WITHIN THE LAST YEAR. ONCE THE INCISION WAS MADE, THE SURGEON NOTICED SOME BLACK BUBBLES SURROUNDING THE SUTURES. ONCE WE GOT A LITTLE DEEPER, THE HUMERAL HEAD WAS REMOVED ALONG WITH THE REPLICATOR PLATE AND SCREW. THE SURGEON DECIDED TO LEAVE THE STEM ALONE AND MOVE ON TO REMOVING THE CAGED GLENOID. HE WAS ABLE TO REMOVE IT WITH JUST THE SUCTION CATHETER AS IT HAD SNAPPED FROM THE CAGE. CAGE WAS REMOVED WITH THREADED CAGE EXTRACTOR ON A SLAP HAMMER. THERE WAS A LOT OF GLENOID BONE LOSS AND MEDIALIZATION. OUR EXTENDED CAGE IMPLANT WAS USED ALONG WITH OUR SCREWS AND A 36MM +4MM LATERALIZED GLENOSPHERE. OUR TRIALS WERE SPINNING ON THE STEM IMPLANT THAT WAS LEFT IN PLACE WHEN TRIALING THE LINER AND TRAY. WE OPENED UP IMPLANTS AND THEY WERE SPINNING AS WELL ON THE STEM IMPLANT. BECAUSE OF THIS WE WERE NOT ABLE TO IMPLANT THEM DUE TO THE THREADS BEING DAMAGED IN THE PRESERVE STEM. PRESERVE STEM WAS EXPLANTED AND THE SURGEON USED A COMPETITOR DEVICE FOR THE HUMERAL SIDE. ALL PARTS AND PIECES WERE REMOVED FROM THE WOUND SITE. THERE

  Patient problems: Failure of Implant; Metal Related Pathology; Pain

  MAUDE report 19298169 ↗
• InjuryMay 13, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE 62 YEAR OLD FEMALE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2020. THE PATIENT COMPLAINED OF PAIN AND WAS REVISED ON (B)(6) 2024. EVERYTHING WAS LOOSE. 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Osteolysis; Pain

  MAUDE report 19297786 ↗
• InjuryMay 13, 2024Fracture; Detachment of Device or Device Component; Naturally Worn; Fracture; Detachment of Device or Device Component; Naturally Worn

  AS REPORTED, THE 73 YEAR OLD FEMALE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2022. THE PATIENT UNDERWENT A REVISION OF THE FAILED ANATOMIC SHOULDER ARTHROPLASTY ON (B)(6) 2024. THE REASON FOR THE REVISION WAS THE GLENOID. ON X-RAY IT WAS CLEAR THE PEGS HAD DISASSOCIATED FROM THE POLY, NO TRAUMA REPORTED, CUFF STILL INTACT. UPON REMOVAL OF THE IMPLANT, ONLY THE SUPERIOR PEG REMAINED, BOTH POSTERIORS WERE DISSOCIATED AND CENTRAL CAGE WAS GROWN IN. IT IS WORTH NOTING THE POLY DID NOT BREAK OFF CLEANLY FROM THE CENTRAL PEG AND THE THREADED PORTION STILL CONTAINED POLY. TREPHINE DRILL WAS USED TO EXTRACT. IT'S LIKELY THE POLY WAS THEN RUBBED AGAINST THE CAGE, RESULTING IN LOSS OF POLY. THE PATIENT WAS REVISED TO A STANDARD SMALL BASEPLATE, LOTS OF GLENOID BONE LOSS, NO IMMEDIATE SIGNS OF INFECTION BUT TISSUE SAMPLES WERE TAKEN. 6MM PRESERVE STEM RETAINED. ALL PARTS, PIECES AND FRAGMENTS WERE REMOVED FROM THE PATIENT WOUND SITE. 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

  MAUDE report 19297591 ↗
• InjuryApr 25, 2024Fracture; Fracture

  AS REPORTED, THE 77 YEAR OLD FEMALE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6)2016. THE PATIENT WAS REVISED ON (B)(6)2024 DUE TO A FAILED GLENOID/DISASSOCIATION. 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19185842 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 60-YEAR-OLD WHITE FEMALE HAD A LEFT TSA ON (B)(6) 2021. THE PATIENT PRESENT WITH PAIN ON (B)(6) 2024. THE PATIENT EXPERIENCED WORSENING PAIN OVER SEVERAL MONTHS WITHOUT INCITING EVENT, IMAGES DEMONSTRATED GLENOID LOOSENING. THE PATIENT IS UNDERGOING CONTINUED OBSERVATION, ACTIVITY MODIFICATION, AND CONSIDERATION OF REVISION SURGERY. THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND UNLIKELY RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19163633 ↗
• InjuryApr 22, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, THE 72 Y/O FEMALE PATIENT HAD COMPLAINED OF PAIN FOR APPROXIMATELY 4 YEARS (IMPLANTS WERE PUT IN 7-8 YEARS AGO). HOWEVER, DUE TO COVID IT HAD NOT BEEN POSSIBLE TO X-RAY/CT THE PATIENT SO THE SURGEON IS NOT FULLY CLEAR WHAT ROUTE OF DETERIORATION HAD BEEN TAKING PLACE. PATIENT FIRST STAGE REVISION OF A CAGED GLENOID ANATOMIC. ALL IMPLANTS REMOVED AND REPLACED WITH A SPACER. THE PATIENT'S ROTATOR CUFF FAILED. PATIENT LOST FUNCTION. DURING THE SURGERY THE 3 X PERIPHERAL PEGS AND ATTACHED POLYETHYLENE WERE RETRIEVED. THE CAGED GLENOID APPEARED TO HAVE SIGNIFICANTLY 'ERODED' WITH POSSIBLE EROSION AFTER BEING LODGED UNDER THE HUMERAL HEAD. THE MEDIAL CALCAR HAD ALSO COMPLETELY DISAPPEARED DUE TO POSSIBLE STRESS SHIELDING. THERE WAS SIGNIFICANT METALOSIS OBSERVED LEADING TO THE BELIEF THAT THIS COULD HAVE BEEN THE CAGE. THERE WAS NO EVIDENCE OF THE CAGE BEING ANYWHERE ELSE (AS PER X-RAYS AND CT'S). THE SURGEON EXPLORED ALL REASONABLE OPTIONS TO FIND IT BUT THERE WAS NO SIGHT OF IT. 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 PHOTOS AND X-RAYS. THE DEVICES A

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

  MAUDE report 19154225 ↗
• InjuryApr 3, 2024Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  AS REPORTED, THE 64 YEAR OLD FEMALE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2020. THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO POLY FAILURE. 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PHOTOS & X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO CHAIN OF COMMAND.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19038390 ↗
• InjuryFeb 16, 2024Break; Fracture; Break; Fracture

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 48 YEAR OLD FEMALE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2013 AND PRESENTED WITH BREAKAGE - COMPONENT, 10 YEAR(S) AND 6 MONTH(S) POST INITIAL PROCEDURE ON (B)(6) 2024. BROKEN SCREWS AT THE GLENOID BASEPLATE INTERFACE. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITIELY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THE REPORT ALSO INDICATES THAT THE ACTION TAKEN WAS REVISION ON (B)(6)2024 WITH THE REMOVAL OF THE FOLLOWING COMPONENTS: STANDARD HUMERAL STEM, REPLICATOR PLATE, TORQUE SCREW, HUMERAL HEAD, GLENOID.. THE OUTCOME IS REPORTED AS RESOLVED. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18724351 ↗
• 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) 2018. THE PATIENT PRESENTED ON (B)(6) 2021 WITH ASEPTIC GLENOID LOOSENING. PATIENT HAS BEEN HAVING INCREASING LEFT SHOULDER PAIN. X-RAYS SHOW GLENOID COMPONENT LOOSENING. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICE AND/ TO PROCEDURE. OUTCOME IS RESOLVED BY REVISION ON (B)(6) 2021. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY. EBI INITIAL SURGERY ATTACHED.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 18467608 ↗
• InjuryAug 24, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS 50 Y/O MALE PATIENT WAS REVISED DUE TO ASEPTIC GLENOID LOOSENING APPROXIMATELY 3.5 YEARS POST INITIAL TSA. PATIENT HAS BEEN HAVING INCREASING LEFT SHOULDER PAIN. X-RAYS SHOW GLENOID COMPONENT LOOSENING. 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; Implant Pain

  MAUDE report 17612560 ↗
• InjuryAug 8, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA CLINICAL STUDY, THAT APPROXIMATELY 4 YEARS POSTOP THE INITIAL IMPLANT, THIS 70 YO FEMALE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. THE PATIENT WAS REVISED TO NON-EXACTECH DEVICE. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED. DEVICES WILL NOT BE RETURNED.

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

  MAUDE report 17484803 ↗
• InjuryAug 1, 2023Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA CLINICAL STUDY THAT THE 70 YO MALE PATIENT EXPERIENCED DISASSOCIATION OF POLYETHYLENE. THE X-RAY DEMONSTRATED LOOSE CAGE GLENOID POLY. THE DATE OF EVENT ONSET IS UNKNOWN. THE PATIENT WAS REVISED ON (B)(6) 2023. THE OUTCOME WAS LAST KNOWN AS RESOLVED.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 17439329 ↗
• InjuryJul 6, 2023Loosening of Implant Not Related to Bone-Ingrowth; Lack of Effect; Loosening of Implant Not Related to Bone-Ingrowth; Lack of Effect

  IT WAS REPORTED VIA CLINICAL STUDY THAT THE 62 YO FEMALE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING WITH LOSS OF MOTION AND SUDDEN SHOULDER PAIN. THE DATE OF EVENT ONSET IS (B)(6) 2023. THE PATIENT WAS REVISED ON (B)(6) /2023. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED.

  Patient problems: Implant Pain

  MAUDE report 17268401 ↗

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-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-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-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