Equinoxe 320-15-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10885862186706), received between Oct 18, 2019 and Mar 25, 2026 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (8 reports).

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.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 3 WEEKS AND 4 DAYS POST THE PATIENTS PREVIOUS REVISION SURGERY, THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING THAT WILL REQUIRE THE PATIENT TO HAVE ANOTHER REVISION SURGERY. NO ACTION TAKEN AT THIS TIME. THE OUTCOME IS CONSIDERED TO BE CONTINUING.

  Patient problems: Aseptic loosening

  MAUDE report 24687409 ↗
• InjuryMar 11, 2026Loss of Osseointegration

  AS REPORTED, THE PATIENT UNDERWENT AN INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS INFECTED AND DEBRIDEMENT, ANTIBIOTICS AND IMPLANT RETENTION WAS PLANNED. THE GLENOID PLATE WAS FOUND TO BE LOOSE AND WAS REMOVED. THE TRAY AND LINER WERE ALSO REMOVED. WOULD HAVE PLACED AN ANATOMIC HUMERAL HEAD TO CREATE A HEMI, BUT THIS WAS NOT AVAILABLE, SO THE STEM AND HRP WERE LEFT IN-SITU. THE PATIENT HAS NO 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: Medical device site infection; Septic loosening; Unspecified Infection

  MAUDE report 24567583 ↗
• InjuryJun 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT RECEIVED A REVERSE OVER A BONE BLOCK 4 YEARS AGO. THERE WAS BONE BLOCK RESORPTION OVER TIME AND THE GLENOID BROKE OUT. THE PATIENT WAS REVISED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Aseptic loosening; Osteolysis

  MAUDE report 22342830 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 9 DAY(S) POST-OPERATIVE OF A RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED GLENOID/CORACOID FXS WHICH LOOSENED GLENOID. PATIENT DOES NOT REPORT INJURY, BUT GLENOID COMPONENT WAS FOUND TO HAVE SHIFTED AT INITIAL POST-OP APPOINTMENT. AT THIS POINT, THE FIRST STAGE OF A STANDARD REVERSE WITH PRESERVE STEM REVISION WAS PERFORMED WITH THE REPORTED REMOVAL OF THE HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, AND GLENOSPHERE LOCKING SCREW COMPONENTS. PATIENT WAS LEFT WITH RESECTION ARTHROPLASTY TO ALLOW GLENOID BONE GRAFT AND BASEPLATE TO HEAL. FOUR MONTHS FOLLOWING, THE PATIENT EXPERIENCED PAIN AND STIFFNESS AND DID NOT TOLERATE RESECTION ARTHROPLASTY AND ELECTED TO PROCEED WITH FINAL IMPLANTATION. IN THE FINAL STAGE OF REVISION, LATARJET PROCEDURE WAS PERFORMED AND NEW SMALL BASEPLATE WAS PLACED WITH TWO LOCKING SCREWS (ANTERIOR, INFERIOR). CERCLAGE WIRE WAS USED TO STABILIZE HUMERAL STEM, WHICH WAS LEFT IN PLACE. 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 COLL

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 20779836 ↗
• 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 1 YEAR(S) AND 6 MONTH(S) POST-OPERATIVE OF RIGHT IMPLANTED TSA, THE PATIENT PRESENTED WITH DISASSOCIATION OF BASE PLATE. PATIENT HAD A SUBSTANTIAL RECONSTRUCTION PROCEDURE DONE TO IMPLEMENT THE RTSA PROSTHESIS. THIS FAILED, AND THE PATIENT WILL UNDERGO SURGERY AGAIN. PATIENT HAD BEEN EXPERIENCING A SUDDEN INCREASE IN PAIN AND WAS FOUND TO HAVE A COMPLETE DISASSOCIATION OF THE BASEPLATE.

  Patient problems: Pain

  MAUDE report 19571228 ↗
• InjuryMay 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT THIS 69 Y/O MALE PATIENT WAS REVISED APPROXIMATELY 2 YEARS 5 MONTHS POST OP. THE REVISION WAS DUE TO FRACTURE OF THE ANCHORING PIN OF THE GLENOID PLATE.

  Patient problems: Failure of Implant

  MAUDE report 19392020 ↗
• InjuryFeb 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 68-YEAR-OLD MALE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6)2013 AND PRESENTED WITH ASEPTIC GLENOID LOOSENING ON (B)(6)2023. (B)(6)2013 X-RAY SHOWED EARLY LUCENCY AROUND RTSA BASEPLATE THAT HAD BEEN REVISED FROM TSA WITH BONE GRAFTING. APPEARED STABLE AND TOLERABLE UNTIL (B)(6)2023. HAD SUDDEN PAIN WHILE BRUSHING TEETH. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE ACTION TAKEN WAS REVISION ON (B)(6)2024. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY 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: Failure of Implant; Pain

  MAUDE report 18763459 ↗
• InjuryJul 17, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA CLINICAL STUDY THAT THE 43 YO MALE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. THE DATE OF EVENT ONSET IS (B)(6) 2022. THE PATIENT WAS REVISED ON (B)(6) 2023. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING.

  Patient problems: Implant Pain; Insufficient Information

  MAUDE report 17338554 ↗
• InjuryFeb 3, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED BY THE EQUINOXE SHOULDER STUDY, THAT THIS 55 Y/O MALE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. AT 2-YEAR FOLLOW-UP VISIT X-RAYS REVEALED GLENOID LOOSENING; HOWEVER, PATIENT REPORTS NO PAIN IN RIGHT SHOULDER. 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. NO ACTION TAKEN, OUTCOME IS CONTINUING.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16291027 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL STUDIES, EQUINOXE SHOULDER STUDY, THAT A 84 YO FEMALE PATIENT, WHO UNDERWENT INITIAL R TSA FOR THE PREOPERATIVE DIAGNOSIS OF OSTEOARTHRITIS ON (B)(6) 2022, HAD AN INTRAOPERATIVE CORACOID FRACTURE DISTAL TO THE CORACOID SCREW. UNLIKELY RELATED TO DEVICES AND POSSIBLY RELATED TO THE PROCEDURE. NO ACTION WAS TAKEN. THE STUDY INDICATES THE OUTCOME AS RESOLVED ON (B)(6) 2022. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF INTRAOPERATIVE BONE FRACTURE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AND SURGICAL PROCEDURE.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 15292483 ↗
• InjuryJun 21, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 8 MONTHS POST OP THE INITIAL TSA, THIS 57 Y/O MALE PATIENT WAS REVISED FOR UNKNOWN REASONS. THIS WAS DISCOVERED WHILE INVESTIGATING CASE-2022-00004984 (1038671-2022-00221 AND 1038671-2022-00222).

  Patient problems: Failure of Implant

  MAUDE report 14763540 ↗
• InjuryJun 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 1 YEAR POST OP THE INITIAL LEFT TSA, THIS 73 Y/O MALE PATIENT WAS REVISED DUE TO PAIN. NO KNOWN EVENT HAS BEEN COMMUNICATED. THE PATIENT DID NOT REPORT A SPECIFIC EVENT. HE PRESENTED TO THE SURGEON'S OFFICE COMPLAINING OF PAIN. X-RAYS SHOWED THAT THE BASEPLATE CONSTRUCT PULLED OUT OF THE GLENOID BONE. THE BASEPLATE/SCREW/GLENOSPHERE CONSTRUCT PULLED OUT OF THE GLENOID BONE. THE SURGEON REMOVED THE HUMERAL LINER, TORQUE SCREW, HUMERAL TRAY, GLENOSPHERE SCREW, GLENOSPHERE, COMPRESSION SCREWS, & BASEPLATE. THE VOID IN THE GLENOID WAS GRAFTED WITH OPTECURE + CCC & CANCELLOUS ALLOGRAFT. THEN, A REPLICATOR PLATE, TORQUE SCREW, & HUMERAL HEAD WAS IMPLANTED. THE HEMIARTHROPLASTY WILL BE LEFT IN PLACE TO ALLOW THE BONE GRAFT IN THE GLENOID TO HEAL BEFORE REVISING TO A REVERSE SHOULDER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 14693353 ↗
• InjuryFeb 22, 2022Adverse 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, APPROXIMAL 7 MONTHS POST OP LEFT SHOULDER REPLACEMENT, THIS (B)(6) PATIENT WAS REVISED FOR A SECOND TIME DUE TO PAIN AND INSTABILITY. THERE WAS LOOSENING OF THE GLENOID AND HUMERAL COMPONENTS WITH IMPLANT BREAKAGE (ONE OF THE BASEPLATE SCREWS). PATIENT HAS POOR HEALTH. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SURGEON WAS HAPPY WITH THE REVISION RESULT. DEVICES WILL NOT BE RETUNING DUE TO THE HOSPITAL DISPOSING OF THEM.

  Patient problems: Failure of Implant

  MAUDE report 13580971 ↗
• InjurySep 21, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE SHOULDER CLINICAL STUDY DATABASE, APPROXIMATELY 19 MOS POSTOP, THIS (B)(6) Y/O FEMALE PATIENT PRESENTED WITH INCREASED LEFT SHOULDER PAIN. IMAGING SHOWED A LOOSE GLENOID COMPONENT AND A REVISION OF THE HUMERAL TRAY, LINER AND GLENOID BASE PLATE. RESOLVED DATE IS NOTED AS (B)(6) 2020. THE CASE REPORT FORM INDICATES THIS EVENT IS NOT RELATED TO DEVICES OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. DEVICES WERE NOT RETURNED. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. CONCOMITANT DEVICES: 320-10-00, EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0, 320-15-06, RS GLENOID PLATE EXT CAG +10MM CAGE PEG.

  Patient problems: Failure of Implant

  MAUDE report 10559676 ↗
• MalfunctionOct 18, 2019Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE INITIAL IMPLANT WAS ON (B)(6) 2013. THE PATIENT HAS CHRONIC DISLOCATION. NO ACTION TAKEN. THE SURGEON IS NOT REVISING BECAUSE THE PATIENT IS 92 YEARS OLD. THE CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICES AND DEFINITELY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Joint Dislocation

  MAUDE report 9208024 ↗