Equinoxe 314-13-13 (UDI 10885862172693)Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10885862172693), received between May 31, 2019 and Aug 11, 2025 — classified as 42 injuries.

The most frequently reported specific device problem is “Naturally Worn” (19 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, 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 42 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2025Fracture; Noise, Audible; Fracture; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE AND WAS IMPLANTED WITH EXACTECH DEVICES. SUBSEQUENTLY, THE PATIENT EXPERIENCED DISASSOCIATION OF POLYETHYLENE. INTERMITTENT PAIN OVER THE PAST COUPLE YEARS. AROUND 1 MONTH AGO, PATIENT REPORTS REACHING TO GRAB SOMETHING AND NOTICING SQUEAKING/PAIN. TSA SHEAR FAILURE. AS A RESULT, APPROXIMATELY 10.5 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION AND WAS REVISED TO A HEMIARTHROPLASTY. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 22773157 ↗
• InjuryAug 4, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4 YEARS AND 4 MONTHS POST THE INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT SHOWED UP IN THE CLINIC WITH HUMERAL PAIN. THE PATIENT SHOWED SIGNS OF HUMERAL STEM LOOSENING AND WAS CONVERTED FROM A PRIMARY SHOULDER TO A COMPETITOR REVERSE TOTAL SHOULDER CONSTRUCT. PHOTOS PROVIDED SHOW WEAR OF THE GLENOID COMPONENT. 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: Implant Pain; Inadequate Osseointegration; Pain

  MAUDE report 22698112 ↗
• InjuryJul 21, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY 7 YEARS POST INITIAL OPERATION. THE POLY HAD BEEN WORN AND BROKEN INTO PIECES. THERE WAS A MAIN FRACTURE ACROSS THE MIDDLE OF POLY. THE PERIPHERAL PEGS AND POLY WERE REMOVED WITH FORCEPS. THE MIDDLE OF THE CENTER CAGE WAS STILL IN THE BONE AND SOLIDLY FIXED. THE REMOVAL TOOL WAS USED TO EXTRACT IN A SINGLE PIECE. THE PATIENT'S ROTATOR CUFF WAS FULLY INTACT. THE PRESERVE STEM WAS EXPOSED PROXIMALLY DUE TO LYTIC LESIONS, BUT WAS NOTED TO BE WELL FIXED. OSTEOLYSIS WAS ALSO OBSERVED ON THE GLENOID SIDE WHICH REQUIRED BONE GRAFTING. PATIENT WAS REVISED FROM AN ANATOMIC TO REVERSE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 22560826 ↗
• InjuryMay 8, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ANATOMIC SHOULDER REPLACEMENT OF THEIR RIGHT SIDE. SUBSEQUENTLY, THE PATIENT REPORTED EXPERIENCING PAIN. AS A RESULT, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION ON APPROXIMATELY 5 YEARS AND 10 MONTHS AFTER INITIAL REPLACEMENT. IT WAS NOTED THAT THE POLY COMPONENT WAS WORN. NO FURTHER PATIENT IMPACT REPORTED.

  Patient problems: Pain

  MAUDE report 21987992 ↗
• InjuryMay 5, 2025Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A 68 YO FEMALE PATIENT WHO HAD A RIGHT SHOULDER IMPLANTED I UNDERWENT A REVISION PROCEDURE. THE PATIENT COMPLAINED OF PAIN. LOOSE GLENOID THAT FAILED INDICATED. POOR PT STATED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN DUE TO CHAIN OF COMMAND. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21965157 ↗
• InjuryMar 19, 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 MILD ASEPTIC GLENOID LOOSENING WITH POSTERO-SUPERIOR CUFF DYSFUNCTION, FIBROSIS OF CUFF. AS A RESULT, APPROXIMATELY 8 MONTHS 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fibrosis

  MAUDE report 21646581 ↗
• InjuryMar 10, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT A MALE PATIENT, INITIAL RIGHT ATSA IMPLANTED IN (B)(6) 2022, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025, APPROXIMATELY 2 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. THE SURGEON REVISED AN ANATOMIC TOTAL SHOULDER BECAUSE OF A FAILED ROTATOR CUFF TO A REVERSE. THE SURGEON KEPT THE HUMERAL STEM. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE NOT ABLE TO BE OBTAINED BY THE SALES REP. DEVICE IMAGES WERE PROVIDED. THE PATIENT HAD A SUCCESSFUL RSA SURGERY. NO FURTHER INFORMATION.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 21569176 ↗
• InjuryFeb 25, 2025Fracture; Detachment of Device or Device Component; Naturally Worn; Fracture; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED A FEMALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED IN (B)(6) 2018, UNDERWENT A REVISION PROCEDURE, DATE UNKNOWN. THE CAGE GLENOID DISSOCIATED. THE POLY HAS SEPARATED FROM THE CAGE. THIS CAUSED THE PATIENT TO HAVE A REVISION TO REMOVE THE BROKEN PARTS. NO PARTS OR PIECES FELL INTO THE WOUND SITE. ALL PARTS AND PIECES WERE REMOVED. THERE WERE NO 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 NOT AVAILABLE FOR RETURN DUE TO CHAIN OF COMMAND AT THE FACILITY. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 21462607 ↗
• InjuryFeb 11, 2025Fracture; Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Detachment of Device or Device Component; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 69 YO MALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED IN (B)(6) 2017, UNDERWENT A CONVERSION OF AN ANATOMIC SHOULDER TO A REVERSE APPROXIMATELY 7 YEARS 8 MONTHS POST. THE SURGEON SUSPECTED THE GLENOID IMPLANT HAD DISASSOCIATED. UPON FINDING THE CENTRAL PEG HAD DISASSOCIATED. THE SURGEON REVISED TO A COMPETITOR'S 42 MM GLENOSHPERE WHILE RETAINING THE ALREADY IMPLANTED HUMERAL STEM AND USING A TRAY AND 42MM LINER FROM SAME COMPANY. 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 AT THE HOSPITAL. DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 21356288 ↗
• InjuryJan 21, 2025Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED. PATIENT HAD PAIN THAT LEAD TO X-RAYS. OBSERVATION SHOWED MIGRATION ON THE PE AND THE PERIPHERAL PEGS. ONLY THE CENTRAL PEG WAS STILL IN PLACE, IT WAS INITIALLY CEMENTED. THE PATIENT WAS CONVERTED TO A REVERSE WITH A BASEPLATE+10MM AND BONE GRAFT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis; Pain

  MAUDE report 21203395 ↗
• InjuryJan 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT THIS PATIENTS RIGHT SHOULDER WAS REVISED. PATIENT HAD A FAILED ANATOMIC CONVERTED TO REVERSE SHOULDER ARTHROPLASTY. SURGEON KEPT STEM, USED A ZERO TRAY AND LINER, AND USED A COMPETITORS GLENOID AND GLENOSPHERE. GLENOID WAS FRACTURED, REMOVED ALL FRAGMENTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21080829 ↗
• InjuryDec 4, 2024Fracture; Fracture

  AS REPORTED, APPROXIMATELY 5 YEARS AND 10 MONTHS POST INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY (TSA), A REVISION WAS PERFORMED DUE TO GLENOID FAILURE AND OSTEOLYSIS OF THE HUMERUS (CALCAR). THE PATIENT WAS REVISED TO A COMPETITOR REVERSE SHOULDER. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Osteolysis

  MAUDE report 20845710 ↗
• InjuryNov 4, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY 5 YEARS 2 MONTHS POST OP. THIS WAS A REVISION OF A STEMLESS ATSA, LEGACY CAGE GLENOID FAILURE AND POLY WEAR. REMOVAL OF EXACTECH STEMLESS ATSA WITH LEGACY CAGE GLENOID, POLY/LINER FAILURE AND EXTREME POLY WEAR, DISASSOCIATION FROM PEGS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20599783 ↗
• InjuryOct 21, 2024Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 93 MONTHS AFTER A LEFT TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, SIGNIFICANT INCREASED PAIN EXACERBATED WITH ALL ACTIVITIES IN HIS LEFT SHOULDER. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Emotional Changes; Joint Laxity; Osteolysis; Pain

  MAUDE report 20498148 ↗
• InjurySep 4, 2024Crack; Fracture; Naturally Worn; Crack; Fracture; Naturally Worn

  IT WAS REPORTED THAT THIS 68 Y/O MALE PATIENT'S LEFT SHOULDER WAS REVISED APPROXIMATELY 10 YEARS 2 MONTHS POST OP. SURGEON REVISED A FAILED RESURFACING-ANATOMIC SHOULDER WITH CAGED GLENOID. THERE WERE SIGNS OF POLYETHYLENE WEAR AND METALLOSIS. THE CENTRAL CAGE HAD SEPARATED FROM THE REST OF THE CAGED GLENOID COMPONENT. SURGEON REVISED TO A COMPETITORS DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 20140137 ↗
• InjuryAug 22, 2024Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 7 MONTH(S) AND 27 DAY(S) POST-OPERATIVE OF A LEFT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING AND DISASSOCIATION OF THE POLYETHYLENE. PATIENT ROLLED OVER IN HIS SLEEP AND FELT A POP IN HIS SHOULDER. DISSOCIATED POLYETHYLENE FROM CENTER CAGE. THE PATIENT UNDERWENT STANDARD TOTAL REVISION AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 20043272 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S SHOULDER WAS REVISED APPROXIMATELY 3 YEARS 5 MONTHS POST OP. IT WAS REVISED FROM ANATOMIC TO REVERSE. REASON FOR THE REVISION WAS DUE TO INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 19611373 ↗
• InjuryJun 1, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 8.5 YEARS POST INITIAL RIGHT TSA, THE 57 Y/O FEMALE PATIENT HAD A REVISION DUE TO POLY WEAR AND RECENT SHOULDER RECALL. PATIENT WAS CHANGED FROM ANATOMIC TO REVERSE. 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/X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO DEVICES WERE DISPOSED AT HOSPITAL.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19441925 ↗
• InjuryMay 22, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THIS 74 Y/O MALE PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY 7 YEARS 3 MONTHS POST OP DUE TO PAIN. PATIENT HAD A GLENOID POLY FAILURE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. DEVICE IS RETURNING.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 19373747 ↗
• InjuryMay 20, 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, APPROXIMATELY SIX YEARS POST INITIAL RIGHT TSA, THE 71 Y/O MALE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING, THE PATIENT MAY HAVE ROTATOR CUFF TEAR. PATIENT THREW PIECE OF WOOD AND INJURED RIGHT SHOULDER. THE EVENT STILL ONGOING. PER CLINICAL REPORT, THE EVENT IS NOT RELATED TO THE DEVICE OR TO THE PROCEDURE.

  Patient problems: Insufficient Information; Muscle/Tendon Damage

  MAUDE report 19356365 ↗
• InjuryFeb 29, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 5 YEAR(S) AND 20 DAY(S) POST-OPERATIVELY OF INITIAL IMPLANTATION OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL TRIAL STUDY THAT THE PATIENT PRESENTED WITH POLYETHYLENE WEAR (WITH OR WITHOUT OSTEOLYSIS). X-RAYS AND MONITORING SHOWED AND LEAD TO THE PATIENT SEEKING A STANDARD TOTAL WITH PRESERVE STEM REVISION 10 MONTHS LATER, IN WHICH THE STEM AND GLENOID WERE REPLACED. DURING THE SURGERY, IT WAS REPORTED DEEP INFECTION WITH ASEPTIC GLENOID LOOSENING. THE OUTCOME OF THIS EVENT IS NOW CONSIDERED RESOLVED, AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY 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: Aseptic loosening; Failure of Implant; Medical device site infection; Pain

  MAUDE report 18810107 ↗
• 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 05-SEP-2017 AND PRESENTED ON 20-APR-2018 WITH ASEPTIC GLENOID LOOSENING. PATIENT BEGIN LIFTING HEAVY WEIGHTS IN THE GYM. HAD UNEXPLAINED SHOULDER PAIN AND SIGNS OF SUBSCAPULARIS TEAR. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICE AND/ TO PROCEDURE. OUTCOME IS RESOLVED BY REVISION (B)(6) 2018. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY. EBI INITIAL SURGERY ATTACHED.

  Patient problems: Failure of Implant; Implant Pain; Muscle/Tendon Damage

  MAUDE report 18465255 ↗
• InjuryDec 20, 2023Adverse 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, 62 YO MALE PATIENT PRIMARY ANATOMIC SURGERY WAS ON (B)(6) 2014. PATIENT WAS REVISED AND CONVERTED TO A REVERSE ON (B)(6) 2022, IN WHICH THE ORIGINAL STEM WAS KEPT. THE SURGEON MENTIONED THAT THE PATIENT DISAPPEARED OR WENT OFF FOR A WHILE POST FIRST REVISION IN 2022, ALLUDING TO MAYBE HIM DOING SOMETHING THAT CAUSED THE IMPLANT TO BREAK, BUT NOTHING SPECIFIC IS KNOWN.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18370184 ↗
• InjuryDec 6, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6)2014. THE PATIENT PRESENTED ON (B)(6) 2023 WITH ASEPTIC GLENOID LOOSENING. INITIALLY NOTED GLENOID LOOSENING ON (B)(6) 2021 X-RAY. HAD INCREASING PAIN & LOOSENING IN LAST YEAR. SUPRASPINATUS WAS ABSENT AT THE TIME OF REVISION SURGERY & GLENOID WAS WORN AND LOOSE. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. OUTCOME WAS RESOLVED ON (B)(6) 2023.

  Patient problems: Failure of Implant; Muscle/Tendon Damage; Pain

  MAUDE report 18280170 ↗
• InjuryOct 3, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  THE GLENOID COMPONENT WAS NOT BROKEN OR LOOSE. I'M GUESSING THE PATIENT'S RC HAD DETERIORATED AND WAS UNSTABLE, OR MAYBE THE NINE-YEAR-OLD POLY WAS STARTING TO WEAR.

  Patient problems: Arthropathy; Failure of Implant; Joint Laxity

  MAUDE report 17859771 ↗

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-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-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