Equinoxe 320-15-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10885862086488), received between Jul 2, 2019 and Mar 17, 2026 — classified as 43 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (18 reports).

13 other recalls cover devices cleared under the same FDA submission (K063569); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA A CLINICAL STUDY, THAT A 67 YO MALE PATIENT, WHO HAD A RTSA, UNDERWENT A REVISION PROCEDURE DUE TO ASEPTIC GLENOID LOOSENING. A LOOSE GLENOID BASEPLATE, PAIN THEN BROKEN SCREW AND FUNCTIONAL LOSS NECESSITATED THE REVISION. THE TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, GLENOSPHERE LOCKING SCREW, GLENOID BASE PLATE, AND COMPRESSION SCREW / LOCKING CAP WERE REVISED. THE STUDY INDICATED IT WAS POSSIBLY RELATED TO THE DEVICES AND THE PROCEDURE. THE OUTCOME STATED RESOLVED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT. THIS IS 1 OF 2 EVENTS FOR THIS PATIENT.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 24624294 ↗
• InjuryDec 31, 2025Structural Problem; Structural Problem

  AS REPORTED, APPROXIMATELY 2 MONTHS AND 15 DAYS POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, IT APPEARED THAT THE GLENOSPHERE HAD LOOSENED/NOT BEEN IMPLANTED PROPERLY AND WEAR EVIDENCE WERE SHOWN ON THE LINER AND HUMERUS. THE PATIENT WAS REVISED. EVERYTHING WAS REMOVED AND A NEW REVERSE SHOULDER WAS IMPLANTED. 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: Erosion

  MAUDE report 23934049 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, FOLLOWING AN INITIAL REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT EXPERIENCED A FRACTURED SCAPULA SPINE AND UNDERWENT OPEN REDUCTION WITH INTERNAL FIXATION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 23464996 ↗
• InjuryOct 24, 2025Migration; Migration

  AS REPORTED, THE SURGEON SCHEDULED THE REVISION OF THE 74 YEAR-OLD FEMALE PATIENT SHOULDER APPROXIMATELY FIVE YEARS POST RIGHT TSA. AT SOME POINT THE GLENOID BASEPLATE SHIFTED ANTERIOR AND ONE OF THE BASEPLATE SCREWS BROKE. THE SURGEON REMOVED THE COMPONENTS INCLUDING THE BROKEN SCREW. HE THEN USED AN ULTRADRIVE TO REMOVE REMAINING CEMENT FROM THE HUMERAL SHAFT. THE SURGEON REPLACED IT WITH A 7MM INTERSPACE ANTIBIOTIC SPACER USING ONE BAG OF PALACOS RG CEMENT. PATIENT WAS REVISED TO AN INTERSPACE SHOULDER SIZE 7MM. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL KEPT THE IMPLANTS.

  Patient problems: Insufficient Information

  MAUDE report 23379162 ↗
• InjurySep 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, 13 DAYS LATER, THE PATIENT REPORTED SLEEPING ON THE OPERATED SHOULDER AND WAS DIAGNOSED WITH DISASSOCIATION OF THE GLENOSPHERE COMPONENT. AS A RESULT, ONE (1) MONTH AND FIVE (5) DAYS AFTER INITIAL IMPLANT SURGERY, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. THE PATIENT OUTCOME WAS REPORTED AS RESOLVED FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23096878 ↗
• InjuryAug 26, 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 REVERSE TOTAL SHOULDER REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN. IMAGING REVEALED A BROKEN SCREW IN THE GLENOID AND WHAT APPEARED TO BE LOOSENING AROUND THE IMPLANT, BOTH GLENOID AND HUMERUS. AS A RESULT, APPROXIMATELY TEN YEARS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. THE STEM WAS WELL FIXED, STABLE AND REMAINS IMPLANTED. METALLOSIS WAS REPORTED WITHIN THE JOINT. INTRAOPERATIVE CULTURES WERE NEGATIVE FOR INFECTION. THE PATIENT REPORTED TO ANESTHESIA THAT AT SOME POINT IN THE PAST, THEY HAD A FALL. IT IS UNKNOWN WHEN THE FALL OCCURRED. 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: Aseptic loosening; Metal Related Pathology; Pain

  MAUDE report 22898935 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. THE PATIENT EXPERIENCED AN INTRAOPERATIVE GLENOID FRACTURE. THE SURGEON CONVERTED TO RTSA WITH AUTOGRAFT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 22748630 ↗
• InjuryJun 25, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED DURING A CLINICAL STUDY THAT APPROXIMATELY 24 MONTHS AFTER A REVISED LEFT REVERSE TOTAL SHOULDER PROCEDURE, A PATIENT EXPERIENCED UNSPECIFIED DEEP INFECTION. THE GLENOID BASEPLATE, SCREWS, GLENOSPHERE AND ADAPTER TRAY WERE EXPLANTED. THE PATIENT WAS REVISED TO A HEMI CONSTRUCT DUE TO GLENOID LOOSENING. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CLINICAL REPORT INDICATES THAT THE EVENT IS DEFINITELY NOT RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE. THIS EVENT WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES, AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 22328362 ↗
• InjuryJun 10, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A 68 YO MALE PATIENT, WHO HAD A LEFT SHOULDER IMPLANTED, UNDERWENT A REVISION PROCEDURE. IT APPEARED THE HUMERAL LINER WAS DISSOCIATED FROM THE HUMERAL PLATE. THE SURGEON BELIEVED THAT THE POLY HAD BEEN DISSOCIATED FOR QUITE SOME TIME PER THE X-RAYS. THE PATIENT HAD SIGNIFICANT METALLOSIS THROUGHOUT THE JOINT. BOTH THE HUMERAL STEM AND GLENOID BASEPLATE WERE LOOSE. THEY WERE REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. PATIENT WILL BE REVISED AT A LATER DATE WITH A CUSTOM GLENOID. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN DUE TO HOSPITAL POLICY. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 5 REPORTS FOR THIS EVENT. THIS IS THE 2ND OF 2 EVENTS FOR THIS PATIENT.

  Patient problems: Inadequate Osseointegration; Metal Related Pathology

  MAUDE report 22178375 ↗
• InjuryMay 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE PATIENT PRESENTED TO THE SURGEON WITH DISASSOCIATION OF THE GLENOSPHERE AND REPORTED PAIN AND FUNCTIONAL IMPOTENCE. APPROXIMATELY 2 YEARS AND 5 MONTHS POST THE INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED AND THE GLENOSPHERE REMOVED. OUTCOME: RESOLVED. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICES OR PROCEDURE.

  Patient problems: Pain

  MAUDE report 22080160 ↗
• InjuryMay 22, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED APPROXIMATELY 78 MONTHS AFTER A LEFT SHOULDER ARTHROPLASTY THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING. IT WAS NOTED POST OPERATIVELY THE STEM AND GLENOID COMPONENTS WERE LOOSE, AND THE SURGEON ELECTED TO REMOVE ALL OF THE SHOULDER COMPONENTS. THE PATIENT WAS A REVISED TO EXACTECH DEVICES. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 22072790 ↗
• InjuryMay 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THIS PATIENT'S LEFT SHOULDER WAS REVISED. SOMETIME AFTER THE INITIAL SURGERY, THE GLENOSPHERE DISASSOCIATED FROM THE BASEPLATE AND ONCE DISCOVERED, REQUIRED REVISION SURGERY TO SECURE THE NEW GLENOSPHERE. SURGEON REMOVED THE IMPLANTS WITH THE EXCEPTION OF THE HUMERAL TRAY WHICH WENT FROM A +0 TO A +5. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22011018 ↗
• InjuryApr 28, 2025Structural Problem; Detachment of Device or Device Component; Naturally Worn; Structural Problem; Detachment of Device or Device Component; Naturally Worn

  THE MALE PATIENT PRESENTED TO SURGEON'S OFFICE IN THE SPRING OF 2023 WITH COMPLAINTS OF SUDDEN AND THEN ONGOING PAIN AND DISSATISFACTION WITH HIS LEFT REVERSE TSA. UPON IMAGING THE IMPLANTS LOOKED MAL-POSITIONED AND THE GLENOID LOOKED LIKE IT HAS BONE GROWTH FROM POLY WEAR. THE SURGEON THOUGHT POLY WEAR AND OSTEOLYSIS CAUSED ONGOING ISSUES AND POTENTIAL LOOSENING OF THE IMPLANTS. THE PATIENT WAS SCHEDULED FOR REVISION LEFT REVERSE TSA. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Metal Related Pathology; Osteolysis; Pain

  MAUDE report 21920606 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S LEFT SHOULDER WAS REVISED APPROXIMATELY 4 YEARS POST INITIAL OPERATION. THE PATIENT HAD AN INFECTION. THE SURGEON REVISED ALL COMPONENTS EXCEPT THE STEM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THERE WAS NO BREAKAGE OF THE DEVICE. THE DEVICES WERE NOT AVAILABLE FOR EVALUATION DUE TO THE DEVICES BEING DISPOSED. NO IMAGES OR RADIOGRAPHS WERE PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 21857973 ↗
• 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, WAS REVISED FOR GLENOID LOOSENING APPROXIMATELY 6 YEARS POST-OPERATIVELY, AND UNDERWENT AN ARTHROSCOPY AND DISTAL CLAVICLE EXCISION, APPROXIMATELY 11 MONTHS FOLLOWING THE REVISION SURGERY. SUBSEQUENTLY, THE PATIENT HAS EXPERIENCED ASEPTIC GLENOID LOOSENING AND DEVELOPED SEVERE PAIN ASSOCIATED WITH LIFTING ACTIVITIES. X-RAYS SHOW EVIDENCE OF GLENOID COMPONENT LOOSENING. COMPONENT IS CLEARLY LOOSE WITH A BROKEN SCREW AND RADIOLUCENCY ABOUT THE SCREWS. THERE IS POSSIBILITY THAT MAY REPRESENT LOW GRADE INFECTION. AS A RESULT, APPROXIMATELY 2.5 YEARS AFTER FIRST REVISION, THE PATIENT UNDERWENT A SECOND RIGHT SHOULDER REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Pain; Unspecified Infection

  MAUDE report 21746128 ↗
• InjuryMar 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY 6 YEARS 7 MONTHS POST INITIAL OPERATION. PATIENT'S GLENOID WAS LOOSE AND WAS REVISED TO A HEMI. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT

  Patient problems: Insufficient Information; Osteolysis

  MAUDE report 21536478 ↗
• InjuryJan 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  APPROXIMATELY 7 MONTH(S) AND 13 DAY(S) POST-OPERATIVE OF A REVISED RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED DISASSOCIATION OF GLENOSPHERE WITH INCREASED PAIN AND SIGNIFICANT POLY WEAR. THE PATIENT WAS PREVIOUSLY REVISED FOR ASEPTIC GLENOID LOOSENING. THE PATIENT UNDERWENT A STANDARD REVERSE WITH PRESERVE STEM REVISION FOR THE DISASSOCIATION WITH THE REPORTED REMOVAL OF THE HUMERAL LINER, GLENOSPHERE, AND GLENOID BASE PLATE COMPONENTS. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES, NO DEVICE RETURN IS ANTICIPATED, AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 21069214 ↗
• InjuryOct 22, 2024Migration; Migration

  IT WAS REPORTED THAT A 74 YO FEMALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED IN (B)(6) 2015, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 9 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT COMPLAINED ABOUT SOME MILD PAIN IN THEIR SHOULDER. THE SURGEON OBTAINED A CT WHICH CONFIRMED REMODELLING OF THE GLENOID WITH THE COMPONENT MIGRATING MEDIALLY AND SUPERIORLY. THE FIRST STAGE REVISION WAS COMPLETED WITH THE STEM LEFT INSITU. A REPLICATOR PLATE AND ANTIBACTERIAL SPACER WERE USED TO COMBAT ANY POTENTIAL INFECTION. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE NOT AVAILABLE. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN, THEY WERE SENT TO RPH FOR STUDY. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 20501672 ↗
• InjuryOct 8, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 4 YEAR(S), 1 MONTH(S) AND 6 DAY(S) POST-OPERATIVE OF A RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING WITH PAIN AND INCREASING RADIOLUCENCY'S/OSTEOLYSIS ON IMAGING. THE PATIENT UNDERWENT STANDARD REVERSE REVISION SURGERY WITH THE REMOVAL OF THE HUMERAL TRAY, HUMERAL LINER, GLENOSHPERE LOCKING SCREW, AND COMPRESSION SCREW/LOCKING CAP. 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: Osteolysis; Pain

  MAUDE report 20403005 ↗
• InjuryOct 8, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 11 MONTH(S) AND 21 DAY(S) POST-OPERATIVE OF A PREVIOUSLY REVISED LEFT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. X-RAYS SHOWED A LOOSE GLENOID SCREW, AND FURTHER IMAGING SHOWED LOOSENING OF THE GLENOID. THE PREVIOUS REVISION WAS DUE TO A SUBSCAPULARIS TEAR OF THE ROTATOR CUFF. THE PATIENT UNDERWENT A STANDARD REVERSE REVISION WITH THE REMOVAL OF THE HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE AND GLENOID BASE PLATE. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 20402089 ↗
• InjuryJul 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 12 MONTHS AFTER A LEFT TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PAIN AND LOOSENING. THE SURGEON REMOVED A LOOSE EQUINOXE GLENOID BASEPLATE AND 42+4 GLENOSPHERE. HE REPLACED THEM WITH A COMPETITOR¿S DEVICES. THERE WAS NO REPORTED SURGICAL DELAY OR BREAKAGE OF A DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE UNABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE SENT TO SPD. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 19726444 ↗
• InjuryJun 19, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 2 YEAR(S) AND 6 MONTH(S) POST IMPLANTATION OF LEFT REVISED TSA, THE PATIENT PRESENTED WITH ASEPTIC GLENOID LOOSENING. DESPITE CT, BONE SCAN, DCE SURGERY, PATIENT HAS DESCRIBED CURRENT SITUATION AS "SEVERE PAIN" IN LEFT SHOULDER. PATIENT IS UNABLE TO USE LEFT SHOULDER FOR BASIC ADLS. STATES ANY MOTION CAUSES PAIN. PAIN IS SHARP, NOT IMPROVING AND PRESENT AT REST BUT MORE SEVERE W/ MOTION. PAIN NOT ASSOCIATED W/ TINGLING, NUMBNESS OR WEAKNESS. THE PATIENT UNDERWENT A STANDARD REVERSE REVISION FOLLOWED BY AN ABX SPACER 2 MONTHS LATER, AND THE EVENT IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THE EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED. PREVIOUS REVISION SUBMITTED UNDER 1038671-2024-01814.

  Patient problems: Implant Pain; Medical device site infection; Pain

  MAUDE report 19568090 ↗
• InjuryApr 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE 83 Y/O MALE PATIENT WAS COMPLAINING OF A SORE SHOULDER. THE SURGEON WAS REVISING THE GLENOID DUE TO SOME LOOSENING. PATIENT'S GLENOID WAS REVISED TO COMPETITOR'S DEVICE. THERE WAS NO BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS AND X-RAYS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO RESIDENT WANTED TO KEEP THEM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 19167245 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 63-YEAR-OLD MALE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6)2019 AND PRESENTED WITH ACROMIAL FRACTURE/STRESS FRACTURE, 0 YEAR(S) AND 11 MONTH(S) POST INITIAL PROCEDURE ON (B)(6)2020. THE OUTCOME OF THIS EVENT IS CONSIDERED UNKNOWN AND NO ACTION WAS TAKEN. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY 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: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 18763222 ↗
• InjuryFeb 12, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY CLINICAL SHOULDER STUDY, THE PATIENT HAD A RIGHT TSA ON (B)(6) 2020. THE PATIENT PRESENTED TO THE CLINIC ON (B)(6) 2020 WITH INCREASED PAIN AFTER BEING OVEREXTENDED IN PHYSICAL THERAPY. CT SCAN SHOWED GLENOID LOOSENING. THE PATIENT WAS REVISED ON (B)(6) 2020.

  Patient problems: Aseptic loosening; Failure of Implant; Pain

  MAUDE report 18692358 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063569. One submission often covers many models, so check the product and lot details in each record.

• Z-2561-2025 · Aug 15, 2025 · Open, Classified
  Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/
• Z-1424-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
• Z-1418-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
• Z-1425-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
• Z-1422-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
• Z-1419-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
• Z-1423-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
• Z-0579-2024 · Nov 21, 2023 · Open, Classified
  Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00,
• Z-3019-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
• Z-3020-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
• Z-0012-2019 · Aug 21, 2018 · Open, Classified
  Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
• Z-0900-2017 · Oct 25, 2016 · Terminated
  Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
• Z-2117-2012 · Jun 15, 2012 · Terminated
  Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.