Equinoxe 300-01-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10885862079305), received between Aug 20, 2020 and Sep 18, 2026 — classified as 26 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (11 reports).

10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Migration

  It was reported that the patient underwent a right shoulder replacement. Subsequently, the patient experienced pain associated with humeral stem subsidence. The patient was last known to be in stable condition following the event. No further information is available.

  Patient problems: Pain

  MAUDE report 50820771 ↗
• InjuryMar 23, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REPORT 2 OF 2 FOR THIS EVENT. AS REPORTED, APPROXIMATELY SIX (6) MONTHS STATUS POST A REVISION OF A TOTAL SHOULDER ARTHROPLASTY DUE TO INFECTION, THIS PATIENT WAS REVISED AGAIN DUE TO INFECTION. AS THE RESULT, SURGEON REMOVED ALL IMPLANTS FROM THE PATIENT. IT WAS NOTED INTRAOPERATIVELY; THE HUMERAL SIDED IMPLANTS WERE LOOSE (CEMENTED IN). PURULENCE WAS OBSERVED ON THE GLENOID SIDE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 24660422 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT, WHO HAD UNDERGONE A CONVERSION FROM AN ANATOMIC TO A REVERSE SHOULDER ON THE LEFT SIDE 4 WEEKS PRIOR, HAD A DISLODGED PROSTHESIS. DURING THE PRIOR CONVERSION, IT WAS NOTED THAT THERE WAS A SUBSTANTIAL DEFECT IN THE GLENOID THAT WAS ADDRESSED WITH ALLOGRAFT PACKING. THERE WERE NO SURGICAL DELAYS OR 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. THEY WERE SENT TO THE HOSPITAL¿S BIO ENGINEERING DEPARTMENT FOR ANALYSIS AND REPORTING. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 3 REPORTS FOR THIS EVENT. THIS IS 1 OF 2 EVENTS FOR THIS PATIENT.

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 24624091 ↗
• InjuryFeb 26, 2026Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 71 YO MALE PATIENT, WHO HAD A LEFT RTSA, UNDERWENT A REVISION PROCEDURE. THE REPORTED INFORMATION INDICATED THE PATIENT HAD A SUCCESSFUL SHOULDER REPLACEMENT; HOWEVER, THE STEM HAS SINCE LOOSENED RESULTING IN A DISLOCATION. ADDITIONAL INFORMATION FROM THE CLINICAL STUDY NOTES THE PATIENT'S DOG JUMPLED ON HIM AND HE FELT A SUDDEN ONSET OF PAIN. X-RAY IMAGES SHOWED DISLOCATION AND MOVEMENT OF THE HUMERAL COMPONENT. AS SUCH, A SINGLE STAGE REVISION WAS UNDERTAKEN, SO THAT THE STEM COULD BE CEMENTED. THEY WERE REVISED TO A RTSA, WITH A CEMENTED STEM FOR ROTATIONAL STABILITY AND AN INCREASE IN LINER SIZE TO 38+2.5MM FOR INCREASED LENGTHENING. THE IMPLANTS WERE REMOVED AND REPLACED WITH NO ISSUES. 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 AVAILABLE FOR RETURN. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Aseptic loosening; Joint Dislocation; Pain

  MAUDE report 24462367 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO A FRACTURED HUMERUS. THE SURGEON REPLACED THE GLENOSPHERE AND LOCKING SCREWS. A COMPETITOR'S STEM WAS PLACED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 23960539 ↗
• InjuryDec 23, 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 ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED AN INFECTION. AS A RESULT, THE SURGEON REPLACED THE HUMERAL STEM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 23880249 ↗
• InjuryNov 17, 2025Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TSA (TOTAL SHOULDER ARTHROPLASTY) ON THE LEFT SIDE. APPROXIMATELY 13 YEARS POST INITIAL OPERATION, THE PATIENT'S HUMERAL STEM SUBSIDED AND BECAME LOOSE FOLLOWING A FRACTURE. THE SURGEON REPLACED THE STEM, GLENOSPHERE, HUMERAL TRAY AND LINER. AN UNCEMENTED STEM WAS IMPLANTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Aseptic loosening; Bone Fracture(s)

  MAUDE report 23570331 ↗
• InjuryAug 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 AND WAS IMPLANTED WITH EXACTECH DEVICES. SUBSEQUENTLY, THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING AND OSTEOLYSIS OF HUMERAL AND GLENOID COMPONENTS. GROSS LOOSENING AT 5 YEAR VISIT. POSSIBLY EXACERBATED FROM FALL 6 WEEKS PRIOR. AS A RESULT, APPROXIMATELY 3 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT REVISION SURGERY. ALL HARDWARE WAS REMOVED DUE TO OSTEOLYSIS OF HUMERAL AND GLENOID COMPONENTS. PATIENT HAD SIGNIFICANT GLENOID BONE LOSS WHICH WAS TREATED WITH A BONE GRAFT. SUBJECT WILL RETURN IN 6 MONTHS TO 1 YEAR FOR CONVERSION TO RTSA. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Osteolysis

  MAUDE report 22692167 ↗
• InjuryMay 16, 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 WITH COMPETITOR'S DEVICES ON THE RIGHT SIDE AND THEN WAS REVISED TO EXACTECH DEVICES. SUBSEQUENTLY, THE PATIENT EXPERIENCED MOBILIZATION OF THE PROSTHETIC STEM, PAIN, AND FUNCTIONAL IMPOTENCE. AS A RESULT, APPROXIMATELY 2 YEARS AFTER IMPLANTATION OF EXACTECH DEVICES, THE PATIENT UNDERWENT AN ADDITIONAL 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; Pain

  MAUDE report 22039978 ↗
• InjuryMar 13, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS PATIENT WAS REVISED. ALL THE COMPONENTS WERE LOOSE AND EASILY REMOVED. COMPETITORS REVERSE WAS THEN PERFORMED AFTER BONE GRAFTING THE DEFECTS. NO ISSUES WITH SURGERY. EXPLANTS NOT AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21597117 ↗
• InjuryNov 7, 2024Unstable; Unstable

  APPROXIMATELY 3 YEAR(S), 8 MONTH(S) AND 5 DAY(S) POST-OPERATIVE OF A LEFT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED A NONUNION OF PERIPROSTHETIC FRACTURE ORIF. PATIENT WAS INITIALLY BEING TREATED NONOPERATIVELY FOR THE PERIPROSTHETIC FRACTURE BUT HAD ACUTE WORSENING OF PAIN AND FEELINGS OF INSTABILITY. PREVIOUSLY, THIS PATIENT EXPERIENCED THREE SEPARATE HUMERAL FRACTURES WITH UNEXPLAINED PAIN, UNDERWENT SEVERAL OPEN REDUCTIONS AS WELL AS WAS SEEN IN THE EMERGENCY DEPARTMENT. ALL EARLIER EVENTS WERE RESOLVED. THE PATIENT UNDERWENT A STANDARD REVERSE REVISION WITH THE REPORTED REMOVAL OF THE STANDARD HUMERAL STEM, HUMERAL TRAY, AND HUMERAL LINER. PATIENT WAS REPORTED TO HAVE BEEN CONVERTED FROM A RTSA TO A HRP. 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/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: Joint Laxity; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 20631088 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  APPROXIMATELY 1 YEAR(S), 8 MONTH(S) AND 24 DAY(S) POST-OPERATIVE OF A LEFT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED HUMERAL FRACTURE AND UNEXPLAINED PAIN. PATIENT SEEN IN CONSULTATION FROM ED FOR WORSENING LEFT SHOULDER PAIN OF 3 DAYS DURATION. X-RAYS IN ED REVEALED WORSENING LOSS OF REDUCTION OF HUMERUS FRACTURE. PATIENT REPORTS WORSENING PAIN WHILE AT WORK WITH RELATED POPPING NOISES. THE PATIENT PREVIOUSLY UNDERWENT CERCLAGE FIXATION FOR A PERIPROSTHETIC HUMERUS FRACTURE. UNFORTUNATELY, THE HARDWARE HAS FAILED. IN EARLIER EVENTS, THE PATIENT EXPERIENCED TWO OTHER HUMERAL FRACTURES THAT WERE RESOLVED THROUGH OPEN REDUCTIONS. THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION WITH SCREWS, PLATE AND CERCLAGE WIRES, MIDSHAFT HUMERUS, WITH ILIAC CREST ASPIRATE GRAFT WITH OPTECURE DUE TO FAILED HARDWARE. NO IMPLANTS WERE REPLACED. 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: Bone Fracture(s); Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 20621046 ↗
• InjurySep 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPRESENTATIVE FOR THE CASE, "BELIEVED THE PATIENT HAD FALLEN OVER - WITH BRITTLE BONE".

  Patient problems: Limb Fracture

  MAUDE report 20165029 ↗
• InjuryAug 28, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS FEMALE PATIENT'S LEFT SHOULDER WAS REVISED. PATIENT HAD LOOSENING OF THE HUMERAL IMPLANTS AFTER 6 YEARS. PATIENT REVISED TO EXACTECH DEVICES. SURGEON PUT A LONG STEM AND KEPT THE GLENOID PLATE.

  Patient problems: Insufficient Information

  MAUDE report 20086753 ↗
• InjuryAug 26, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 10 YEARS POST OP THE INITIAL TSA, THE PATIENT EXPERIENCED PROGRESSIVE HUMERAL LUCENCY ON X-RAY - NOW WITH GLENOID LOOSENING NOTED. NO SPECIFIC MOI NOTED. THE PATIENT UNDERWENT REVISION SURGERY AND THE OUTCOME OF THIS EVENT IS NOW CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICES AND/OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Insufficient Information

  MAUDE report 20065570 ↗
• InjuryJul 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 94 MONTHS AFTER A LEFT TOTAL SHOULDER REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PAIN, LOSS OF FUNCTION AND OSTEOLYSIS. THE LOSS OF FUNCTION WAS NOT A GRADUAL LOSS OF FUNCTION, BUT MORE OF AN ¿ALL OF SUDDEN¿ EVENT PER THE REPORT. UPON EXTRACTING HARDWARE, THE HUMERAL HEAD, REPLICATOR PLATE, AND STEM WERE ALL EXTRACTED WITHOUT MUCH DIFFICULTY. MOVING TO THE GLENOID SIDE, THE GLENOID CAME OUT QUITE EASILY WITH ALL 3 PERIPHERAL PEGS ATTACHED BUT THE CAGE WAS NOT ATTACHED AS IT HAD SNAPPED FROM THE POLY. THE THREADED CAGE EXTRACTION INSTRUMENT WAS THREADED INTO THE CAGE AND A SLAP HAMMER WAS USED TO REMOVE IT. ALL PARTS AND PIECES WERE REMOVED. THE CAGE HAD BROKEN OFF IN THE GLENOID BUT WAS REMOVED IN ITS ENTIRETY. THERE WERE SOME CLEAR SIGNS OF OSTEOLYSIS AS THE GLENOID HAD BECOME QUITE MEDIALIZED. THE SURGEON EXTRACTED ALL HARDWARE AND CONVERTED TO A COMPETITOR¿S DEVICES PER HIS PLAN. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. X-RAYS WERE PROVIDED. THE DEVICE IS NOT AVAILABLE FOR RETURN AS THE HOSPITAL KEPT THEM. DEVICE IMAGES WERE PROVIDED. NO ADDITION

  Patient problems: Osteolysis; Pain

  MAUDE report 19726221 ↗
• InjuryApr 10, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 82 YO FEMALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 6 YEARS 3 MONTHS POST THE INITIAL PROCEDURE. THE REVISION WAS PERFORMED DUE TO ASEPTIC LOOSENING OF THE HUMERAL STEM. THE GLENOSPHERE WAS EXCHANGED FOR AN EXACTECH DEVICE. THE STEM WAS REMOVED AND REPLACED BY A COMPETITOR¿S PRODUCT. THERE WAS NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS FOR ANALYSIS ANTICIPATED AS THEY WERE DISCARDED BY THE HOSPITAL. NO X-RAYS OR DEVICE IMAGES WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION.

  Patient problems: Failure of Implant

  MAUDE report 19084714 ↗
• InjuryApr 9, 2024Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AN 86 YO FEMALE PATIENT, INITIAL RIGHT REVERSE TOTAL SHOULDER IMPLANTED ON (B)(6) 2013, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 10 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT RETURNED TO THE SURGEON¿S OFFICE REPORTING RIGHT SHOULDER PAIN, DISCOMFORT, AND DECREASED MOTION. INITIAL X-RAYS SHOWED POTENTIAL LOOSENING OF COMPONENTS AND INFERIOR SCAPULAR NOTCHING. THE PATIENT DECIDED TO WAIT AND WATCH THEIR SHOULDER BUT THEN BECAME DISLOCATED. UPON RETURNING TO THE SURGEON¿S OFFICE WITH A DISLOCATED PROSTHESIS, SHE WAS BOOKED FOR A RIGHT REVISION OF HER REVERSE TSA IMPLANTATION OF BONE GRAFT AND AN ANTIBIOTIC SPACER. THEY PLANNED TO RETURN AND REIMPLANT A PROSTHESIS AFTER BONE GRAFTING WAS INTENDED. ON (B)(6) 2024 THE PATIENT UNDERWENT REVISION SHOULDER SURGERY. UPON OPENING THE WOUND THE SURGEON NOTED SUBSTANTIAL METALOSIS. THE LINER WAS STILL ATTACHED TO THE TRAY AND HUMERAL STEM, THOUGH THE ENTIRE CONSTRUCT WAS DISLOCATED AND NOT IN A GOOD POSITION AND IT PULLED OUT OF THE HUMERUS BY HAND WITH LITTLE FORCE. THE CEMENT WAS CLEANED AND CLEARED FROM THE HUMERAL BONE AS BEST AS POSSIBLE. THERE WAS FURTHER PROXIMAL BONE LOSS AFTER REMOVA

  Patient problems: Aseptic loosening; Discomfort; Joint Dislocation; Joint Impingement; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 19073940 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY NINE MONTHS POST INITIAL LEFT TSA, THE 78 Y/O FEMALE HAD A REVISION SURGERY DUE TO HETEROTOPIC OSSIFICATION. PATIENT HAD CLEARED OUT BONE AND RE-IMPLANTED HUMERAL COMPONENTS. 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 WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE DEVICES WERE DISPOSED OF BY HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 19035836 ↗
• InjuryAug 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY EQUINOXE SHOULDER STUDY, APPROXIMATELY SEVENTEEN DAYS POST INITIAL TSA, THE 74 Y/O FEMALE EXPERIENCED HUMERAL FRACTURE. EVENT WAS RESOLVED. PATIENT FOLLOW UP AT 1 YEAR POST OP. PATIENT HAPPY WITH OUTCOME AND REALISTIC EXPECTATIONS. PER CLINICAL REPORT THE REPORTED EVENT IS POSSIBLY RELATED TO THE DEVICE AND THE PROCEDURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 17628952 ↗
• InjuryApr 13, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE 77 YEAR OLD FEMALE PATIENT PRESENTED WITH POSTERIOR DISLOCATION OF THE HUMERUS, AND PAIN. THE SURGEON OPENED THE JOINT TO FIND FRANK PUS. THE PATIENT WAS REVISED ON (B)(6) 2023; ALL COMPONENTS WERE REMOVED AND A SPACER PLACED 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Bacterial Infection; Joint Dislocation; Pain; Unspecified Infection

  MAUDE report 16740126 ↗
• InjuryNov 15, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED, APPROXIMATELY 2 MONTHS POST OP OF A LEFT TSA, THIS 63 Y/O MALE PATIENT WAS REVISED TO A REVERSE SHOULDER WITH GRAFT. "THE GRAFT HADN¿T PREVIOUSLY TAKEN FROM THE PREVIOUS REVISION (, THE PATIENT HAD POOR BONE." THERE WAS NO REPORTED ISSUES DURING THE REVISION SURGICAL PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. DEVICES WILL NOT BE RETURNING, DISPOSED OF BY HOSPITAL. NO OTHER INFORMATION IS AVAILABLE. PLEASE REFERENCE (B)(4) FOR PREVIOUS REVISION.

  Patient problems: Failure of Implant

  MAUDE report 15796362 ↗
• InjuryDec 10, 2021Fracture; Fracture

  APPROXIMATELY 4 MONTHS POSTOP THE INITIAL RIGHT TSA, THIS 74 Y/O FEMALE PATIENT PRESENTED WITH A HUMERAL GREATER TUBEROSITY FRACTURE AND WAS REVISED. OUTCOME IS REPORT AS CONTINUING. PATIENT HAS HISTORY OF MALIGNANT MELANOMA AND OSTEOARTHRITIS. DEVICES ARE NOT RETURNING DUE TO STUDY POLICY. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Bone Fracture(s)

  MAUDE report 12974808 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, DURING THE INITIAL PROCEDURE FOR THIS 61 Y/O FEMALE, WHEN PLACING THE RIGHT FINAL STEM, DUE TO THE HARD DIAPHYSEAL BONE, THERE WAS A PERIPROSTHETIC FRACTURE THAT DID EXTEND PAST THE METAPHYSIS. THE STEM WAS STILL STABLE. THE AREA OF THE FRACTURE WAS PACKED WITH HUMERAL HEAD AUTOGRAFT AND A SINGLE CERCLAGE CABLE WAS PLACED. THE CASE REPORTS STATE THE ISSUE WAS RESOLVED ON (B)(6) 2021. THE CASE REPORT FORM INDICATES THIS EVENT IS NOT RELATED TO DEVICES AND POSSIBLY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. DEVICES REMAIN IMPLANTED. PATIENT HAS A HISTORY OF OSTEONECROSIS, ADRENAL INSUFFICIENCY, HYPOTENSION, HYPOTHYROIDISM, STATUS POST CHEMOTHERAPY, AND RECEIVED SUBACROMIAL INJECTION (B)(6) 2020, (B)(6) 2020, AT AN OUTSIDE INSTITUTION.

  Patient problems: Bone Fracture(s)

  MAUDE report 12083217 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED DURING A PRIMARY TSA STANDARD REVERSE ON THIS (B)(6) PATIENT, A NON-DISPLACED PERIPROSTHETIC HUMERAL SHAFT FRACTURE OCCURRED. NON-DISPLACED PERIPROSTHETIC HUMERAL SHAFT FRACTURE DOES NOT ALTER TREATMENT PLAN- HEALING ON FOLLOW UP RADIOGRAPHS. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICES AND DEFINITELY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. PATIENT¿S POSTOP HOSPITAL STAY WAS 2 DAYS. ALL DEVICES REMAIN IMPLANTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 11055239 ↗

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-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 Compone
• 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
• 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 Compone
• 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-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-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-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-0884-2021 · Nov 9, 2020 · Open, Classified
  Equinoxe Humeral Stem, Primary, Press Fit, 11mm
• 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