Equinoxe 300-01-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10885862079312), received between May 23, 2019 and Sep 2, 2026 — classified as 42 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (24 reports).

1 FDA recall record name this device's identifier, 1 still open.

9 other recalls cover devices cleared under the same FDA submission (K042021); 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. Nov 9, 2020Open, Classified

   Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.

   Z-0884-2021 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Naturally Worn

  Patient problems: Joint Dislocation

  MAUDE report 50565337 ↗
• InjuryJun 12, 2026Loss of Osseointegration

  IT WAS REPORTED THAT THIS PATIENT PRESENTED TO SURGEON WITH A PAINFUL SHOULDER AND DECREASED FUNCTION FOLLOWING A RIGHT SHOULDER REPLACEMENT. THE PRE-OP IMAGING AND ASSESSMENT SHOWED WHAT APPEARS TO BE A LOOSE HUMERAL COMPONENT AND INFERIOR SCAPULAR NOTCHING ON THE GLENOID, WITH SOME BONE CHANGES/RESORPTION ON BOTH THE HUMERUS AND GLENOID. IT WAS SUSPECTED THAT THE GLENOID COMPONENT MAY BE LOOSE AS WELL. THE PATIENT WAS SCHEDULED FOR A REVISION REVERSE TOTAL SHOULDER ARTHROPLASTY WITH HUMERAL EXCHANGE AND POSSIBLE GLENOID / COMPLETE REVISION. DURING THE PROCEDURE, IT WAS CONFIRMED THAT THE HUMERAL STEM AND COMPONENT WERE LOOSE AND NOT WELL FIXED IN THE BONE. THE SURGEON WAS ABLE TO PULL THE CONSTRUCT OUT BY HAND NOT NEEDING EXTRACTION TOOLS. THERE WAS NO BONE GROWTH ONTO THE HUMERAL STEM. THE GLENOID BASEPLATE WAS ASSESSED AND SHOWED/PRESENTED TO BE WELL FIXED AFTER TESTING IT WITH A SLAP HAMMER AND LEVERAGE BAR. THE SURGEON DEBRIDED AND IRRIGATED THE SHOULDER JOINT AND KEPT THE WELL-FIXED BASEPLATE IN. A 38MM +4 LATERALIZED GLENOSPHERE WAS REPLACED TO HELP PUSH THE HUMERUS AWAY FROM THE INFERIOR GLENOID BONE, ALONG WITH A NEW HUMERAL STEM THAT WAS CEMENTED INTO THE HUMERAL CANAL A

  Patient problems: Bone Notching; Pain

  MAUDE report 25485848 ↗
• InjuryMay 27, 2026Separation Failure; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT A LEFT SHOULDER REPLACEMENT AND SUBSEQUENTLY REQUIRED A REVISION SURGERY TO ADDRESS PAIN. BASED ON PROVIDED RADIOGRAPH, THE GLENOID COMPONENTS ARE SEEN TO BE NO LONGER BE FIXED WITHIN THE BONE AND APPEAR TO HAVE ROTATED. THE SURGEON¿S PLAN FOR THE REVISION PROCEDURE WAS TO REMOVE THE GLENOSPHERE, RECUT THE HUMERUS, AND IMPLANT NEW HUMERAL COMPONENTS. DURING THE PROCEDURE, THE SURGEON REMOVED THE FIXED-ANGLE TORQUE SCREW AND ATTEMPTED TO REMOVE THE HUMERAL ADAPTER TRAY; HOWEVER, THE STEM DISENGAGED AND WAS REMOVED WITH THE TRAY STILL ATTACHED. ATTENTION WAS THEN TURNED TO THE GLENOSPHERE. AFTER REMOVAL OF THE LOCKING SCREW, THE SURGEON ATTEMPTED TO DISENGAGE THE GLENOSPHERE FROM THE BASEPLATE USING MANUAL MANIPULATION. ADDITIONAL ATTEMPTS WERE MADE, HOWEVER, THE GLENOSPHERE AND BASEPLATE WERE ULTIMATELY REMOVED TOGETHER AS A SINGLE CONSTRUCT. THE SURGEON REMOVED ALL THE IMPLANTS AND MADE A HOMEMADE SPACER AS A FIRST STAGE REVISION PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain

  MAUDE report 25299690 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 59 YO MALE PATIENT, WHO HAD A RIGHT RTSA, UNDERWENT A REVISION SURGERY, APPROXIMATELY 3 YEARS POST THE INITIAL PROCEDURE. THE PATIENT HAD A CONFIRMED PERIPROSTHETIC JOINT INFECTION. THE IMPLANTS WERE REMOVED. A CEMENT SPACER WAS INSERTED FOR THE 1ST OF A 2 STAGE REVISION. 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 NOT AVAILABLE FOR RETURN. THE HOSPITAL IS UNABLE TO RELEASE DUE TO BIOHAZARD RISK. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 24492196 ↗
• InjuryDec 1, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A LEFT ANATOMIC SHOULDER REPLACEMENT, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 3 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. DURING THE HUMERAL HEAD REMOVAL STEP, THE INSITU HUMERAL STEM CAME OUT. SUBSEQUENTLY A FULL REVISION WAS PERFORMED REPLACING ALL IMPLANTS. THERE WERE NO COMPLICATIONS FOR THE PATIENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. THIS IS 1 OF 2 EVENTS FOR THIS PATIENT

  Patient problems: Aseptic loosening

  MAUDE report 23689088 ↗
• InjuryNov 17, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 73 YO MALE PATIENT, WHO HAD A RIGHT TSA, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 6 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS INDICATED FOR SURGERY DUE TO POSSIBLE INFECTION/METALOSIS. UPON EXPOSURE, PUSS WAS NOTED SURROUNDING THE HUMERAL IMPLANTS, WITH SIGNIFICANT BONE LOSS OF THE MEDIAL CALCAR. HUMERAL IMPLANT WAS LOOSE AND EASILY EXPLANTED. GLENOID IMPLANT WAS NO LONGER FIXATED. THE POLYETHYLENE COMPONENT OF THE GLENOID IMPLANT HAD DISASSOCIATED FROM THE CENTRAL METAL CAGE, WHICH HAD FRAGMENTED. THERE WAS SEVERE BONE LOSS IN THE GLENOID. ALL COMPONENTS WHERE EXPLANTED, AND A CEMENT SPACER WAS IMPLANTED. THERE WAS DEVICE BREAKAGE, THE GLENOID CENTRAL CAGE HAD FRAGMENTED. 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. THE HOSPITAL RETAINED THEM FOR ANALYSIS. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Metal Related Pathology; Osteolysis; Unspecified Infection

  MAUDE report 23576556 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE, THE PATIENT¿S GREATER TUBEROSITY BROKE WHILE TRYING TO REMOVE THE STEM. THE SURGEON EXPLAINED TO THE PATIENT THEY WILL PROBABLY REQUIRE A HRP AS PART OF THE 2ND STAGE REVISION. THERE WERE DEVICE BREAKAGES AND THERE WERE FRAGMENTS, PARTS, PIECED IN THE WOUND SITE WHICH WERE REMOVED BY THE SURGEON AND A WASH OUT OCCURRED. 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 AVAILABLE. THIS IS 1 OF 2 EVENTS FOR THIS PATIENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 23287498 ↗
• InjuryJun 24, 2025Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TSA. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HUMERAL FRACTURE WITH AN UNKNOWN CAUSE. AS A RESULT, THE PATIENT UNDERWENT A LEFT SHOULDER REVISION APPROXIMATELY 5 YEARS AND 5 MONTHS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Aseptic loosening; Periprosthetic fracture

  MAUDE report 22322262 ↗
• InjuryJun 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 53 YO MALE PATIENT, WHO HAD ANOTHER COMPANY¿S LEFT SHOULDER COMPONENTS THAT HAD BEEN REVISED TO OUR COMPANY¿S REVERSE COMPONENTS, UNDERWENT A REVISION PROCEDURE. THE HUMERAL STEM WAS LOOSE AND WAS CHANGED TO A CEMENTED STEM AND CONSTRAINED LINER. 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 NOT AVAILABLE. THEY WERE DISPOSED OF BY THE HOSPITAL. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 22287820 ↗
• 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 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. 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 22178832 ↗
• 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 22073095 ↗
• InjuryApr 2, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 7.5 YEARS POST OP THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO THE COMPONENTS BEING LOOSE. REASON FOR THE LOOSENING IS UNKNOWN. SURGEON REMOVED COMPONENTS AND REPLACED WITH ANATOMIC HEMI. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY.

  Patient problems: Insufficient Information

  MAUDE report 21753990 ↗
• InjuryMar 5, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 70 YO FEMALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2024, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. THE PATIENT PRESENTED WITH A DISLOCATION. THE SURGEON DECIDED TO CHANGE THE HUMERAL LINER. WHEN CHANGING THE LINER, IT WAS NOTICED THE STEM HAD COME LOSE. THE SURGEON CHANGED THE STEM, ADAPTER TRAY AND LINER. 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. THEY WERE DISPOSED OF BY THE CUSTOMER. NO DEVICE IMAGES WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION.

  Patient problems: Inadequate Osseointegration; Joint Dislocation

  MAUDE report 21527123 ↗
• InjuryJan 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 1 MONTH(S) POST-OPERATIVE OF A RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED A (OTHER) SCAPULAR FRACTURE. PATIENT¿S ARM WAS JERKED WHILE PUMPING GAS. THE PATIENT UNDERWENT A STANDARD REVERSE REVISION WITH THE REPORTED REMOVAL OF THE STANDARD HUMERAL STEM COMPONENT. THE OUTCOME OF THIS EVENT IS NOW CONSIDERED RESOLVED AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND POSSIBLY RELATED 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: Bone Fracture(s)

  MAUDE report 21236443 ↗
• InjurySep 10, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 3 YEAR(S), 7 MONTH(S) AND 30 DAY(S) POST-OPERATIVE OF A LEFT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. IT WAS REPORTED AS BOTH TSA STEM AND GLENOID LOOSE - POSSIBLY DUE TO FALL.THE PATIENT UNDERWENT STANDARD TOTAL REVISION, AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE.

  Patient problems: Fall

  MAUDE report 20184088 ↗
• InjurySep 9, 2024Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  AS REPORTED, APPROXIMATELY 2 MONTHS POST AN INITIAL RIGHT TSA, THE STEM ROTATED INSIDE THE CANAL AND THE PATIENT DISLOCATED THEIR SHOULDER. THE PATIENT WAS REVISED AND EVERYTHING WAS REMOVED. THE SURGEON DECIDED TO CEMENT IN A STEM AND DO A HIGHER GLENOSPHERE. 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: Joint Dislocation

  MAUDE report 20175941 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST-OPERATIVE OF A LEFT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED A HUMERAL FRACTURE. AVULSION OF THE GREATER TUBEROSITY, AND IT IS NOW DISPLACED POSTERIORLY AND SUPERIORLY. THE PATIENT WAS GIVEN MODIFIED PHYSICAL THERAPY PROTOCOL. THE PATIENT IN NO PAIN, FRACTURED APPEARS HEALED ON X-RAY 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: Bone Fracture(s); Limb Fracture

  MAUDE report 20044751 ↗
• InjuryJul 2, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 3 YEAR(S), 2 MONTH(S) AND 12 DAY(S) POST-OPERATIVE OF A RIGHT TSA, THE PATIENT PRESENTED WITH ASEPTIC HUMERAL LOOSENING. THE PATIENT HAD RIGHT SHOULDER PAIN. RADIOGRAPHS REVEALED RIGHT SHOULDER PROSTHETIC HUMERAL STEM SUBTLE LOOSENING. SURGERY WAS PERFORMED WHERE EXISTING HUMERAL STEM WAS CEMENTED. THE DEVICES REMAIN IMPLANTED, AND THE EVENT IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 19662709 ↗
• InjuryJun 21, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT WHO HAD AN INITIAL RIGHT SHOULDER IMPLANTED IN MARCH OF 2020, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 3 YEARS 7 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT HAD PRESENTED TO THE SURGEON WITH A SORE SHOULDER. DURING THE REVISION PROCEDURE, THE STEM WAS FOUND TO BE LOOSENING. THE SURGEON REMOVED THE HUMERAL STEM AND REPLACED IT WITH A CEMENTED STEM. 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 DEVICE IS NOT AVAILABLE FOR ANALYSIS AS IT WAS DISCARDED BY THE CUSTOMER. DEVICE IMAGES WERE PROVIDED.

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

  MAUDE report 19588166 ↗
• InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, DURING A LEFT REVISION TSA, THE PATIENT EXPERIENCED AN INTRA-OPERATIVE HUMERAL FRACTURE. IT WAS ADDITIONAL REPORTED THAT PER EMAIL RECEIVED "YOU ARE ABSOLUTELY RIGHT THE HUMERAL STEM WAS REMOVED DURING THE FIRST REVISION IN SUMMER OF 2019. THE PATIENT REMAINED WITHOUT ANY IMPLANT IN THE SHOULDER WHILE THE BONE HEALED. THE REVERSE PTE WAS REIMPLEMENTED IN LATE FALL OF 2019" THE PATIENT UNDERWENT A REVISION PROCEDURE, AND THE EVENT IS NOW CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THE EVENT IS DEFINITELY NOT RELATED TO THE DEVICE(S) AND POSSIBLY RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Bone Fracture(s)

  MAUDE report 19506779 ↗
• InjuryJun 7, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 1 YEAR(S) AND 7 MONTH(S) POST IMPLANTATION OF LEFT A SECOND REVISED TSA, THE PATIENT PRESENTED WITH ASEPTIC GLENOID LOOSENING. PATIENT REPORTS SIGNIFICANT LEFT SHOULDER PAIN AND BELIEVES IT IS INFECTED AGAIN. PATIENT FEELS SHOULDER IS " NOT QUITE RIGHT" AGAIN. DENIES CONSTITUTIONAL SYMPTOMS TO INCLUDE FEVERS, CHILLS, NIGHT PAIN. APPROXIMATELY 9 MONTHS EARLIER, THE REPORT INDICATED UNEXPLAINED PAIN IN LEFT SHOULDER. WBC SCAN TO RULE OUT INFECTION BUT HAVING LEFT SHOULDER PAIN. THIS WAS RESOLVED A MONTH LATER AND SCAN NEGATIVE FOR INFECTION. PATIENT HAS NO PAIN AND DOING BETTER. THIS OUTCOME OF THE EVENT WAS RESOLVED BY REPEAT NUCLEAR MEDICINE, WBC SCAN, INFECTION LABS AND FINALLY A STANDARD REVERSE REVISION OF THE LEFT SHOULDER. THE CLINICAL REPORT INDICATES THAT THE EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 19487962 ↗
• InjuryMar 21, 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 BY THE EQUINOXE SHOULDER STUDY, THE 64-YEAR-OLD MALE PATIENT HAD A LEFT TSA ON (B)(6) 2024. THE PATIENT PRESENTED WITH A HUMERAL FRACTURE, INTRA-OPERATIVELY ON (B)(6)2024. GREATER TUBEROSITY FRACTURE DURING THE CASE. BONE WAS EXTREMELY OSTEOPOROTIC. HAD TO USE STANDARD AND CEMENTED STEM AND CONVERT TO RTSA DUE TO OSTEOPOROSIS. THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING AND THE ACTION TAKEN WAS OTHER - CERCLAGE SUTURES AROUND TUBEROSITY AT SURGERY. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT 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: Bone Fracture(s); Limb Fracture

  MAUDE report 18950558 ↗
• InjuryFeb 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY THREE MONTHS POST INITIAL RIGHT TSA, THE 58 Y/O MALE PATIENT PRESENTED WITH RECURRING DISLOCATION DUE TO UNDERSIZED/LOOSE STEM. PATIENT HAD A REPLACEMENT OF STEM, LINER, GLENOSPHERE, TORQUE SCREW, AND LOCKING SCREW. THERE WAS NO REPORTED 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 IMAGES OR X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THEY WERE DISPOSED BY HOSPITAL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18763871 ↗
• InjuryNov 13, 2023Adverse 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, APPROXIMATELY THREE MONTHS INITIAL RIGHT TSA, THE 80 Y/O MALE PATIENT HAD A REVISION AS TO THE HUMERAL STEM HAD BECOME LOOSE DUE TO A HUMERUS FRACTURE. THE SURGEON EXCHANGED STEM, GLENOSPHERE, HUMERAL TRAY AND LINER. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALE REP WAS UNABLE TO OBTAIN X-RAYS OR IMAGES. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISCARDED BY THE HOSPITAL.

  Patient problems: Bone Fracture(s)

  MAUDE report 18123238 ↗
• MalfunctionOct 3, 2023Incorrect Measurement; Device Markings/Labelling Problem; Incorrect Measurement; Device Markings/Labelling Problem

  AS REPORTED, THE AGENT PRESENT DURING THE SURGERY UNDERSTOOD THERE WAS A PROBLEM WHEN THE SURGEON INSERTED THE STEM (IMPLANT), IT SEEMED TO NOT FIT PROPERLY , THE STEM WAS NOT PROGRESSING AS EXPECTED, HE REMOVED IT AND SAW IT WAS IN FACT A SIZE 12 THAT HAS BEEN PACKAGED IN AN IMPLANT BOX SIZE 11. THERE WAS NO AVERSE EVENT DUE TO THE DELAYED. THE INITIAL INDICATION FOR PATIENT'S TSA WAS SHOULDER ARTHRITIS SECONDARY TO ROTATOR CUFF TEAR. PHOTO RECEIVED. THE DEVICE WILL BE RETURN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17858373 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042021. One submission often covers many models, so check the product and lot details in each record.

• Z-0537-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Compo
• Z-0536-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: N
• Z-0535-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: N
• Z-1405-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02
• Z-1403-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Nu
• Z-1402-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item
• Z-1404-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Nu
• Z-1459-2015 · Feb 13, 2015 · Terminated
  Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
• Z-2115-2012 · Jun 15, 2012 · Terminated
  Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty