Equinoxe 320-15-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862242563), received between Aug 5, 2019 and Apr 25, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2025Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth; Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED, THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE WITH COMPETITOR'S DEVICES; THEN REVISED TO EXACTECH PRODUCTS FOR UNKNOWN REASONS. SUBSEQUENTLY, THE PATIENT EXPERIENCED AN INFECTION WITH LOOSE BASEPLATE. AS A RESULT, APPROXIMATELY 2 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT EXPLANTATION OF DEVICES AND IMPLANTATION OF ANTIBIOTIC SPACER TO RIGHT SHOULDER. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Pain; Septic loosening; Unspecified Infection

  MAUDE report 21913986 ↗
• InjuryOct 8, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 5 YEAR(S) AND 2 DAY(S) POST-OPERATIVE OF A REVISED RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED SEPTIC LOOSENING. IT WAS FURTHER STATED; FAILED BASEPLATE OF REVISION RTSA WITH GROSS PURULENCE. IN THE EARLIER REVISION, THE PATIENT EXPERIENCED INSTABILITY AND DISLOCATION THAT WAS RESOLVED WITH THE REMOVAL OF THE HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, AND GLENOSPHERE LOCKING SCREW. THE PATIENT UNDERWENT ANOTHER STANDARD REVERSE REVISION WITH THE REMOVAL OF THE STANDARD HUMERAL STEM, TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, GLENOSPHERE LOCKING SCREW, GLENOID BASE PLATE, AND COMPRESSION SCREW/LOCKING CAP. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE(S) AND DEFINITELY RELATED TO THE PROCEDURE.

  Patient problems: Medical device site infection

  MAUDE report 20402788 ↗
• InjuryJul 18, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 6 YEAR(S), 3 MONTH(S) AND 27 DAY(S) POST-OPERATIVE OF A RIGHT TSA, THE PATIENT PRESENTED WITH DISASSOCIATION OF POLYETHYLENE. SUBJECT PRESENTED WITH EXTRUDED POLY FROM TRAY AFTER USING HEAVY HEDGER; DURING SURGERY IT WAS NOTED THAT BASEPLATE WAS ALSO LOOSE. THE PATIENT UNDERWENT STANDARD REVERSE WITH PRESERVE STEM REVISION SURGERY AND THE OUTCOME IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19776430 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY TWO YEARS POST INITIAL RIGHT TSA, THE 55 Y/O FEMALE PATIENT EXPERIENCED STIFF SHOULDER. AFTER SHOULDER REPLACEMENT, PATIENT UNDERWENT A TENDON TRANSFER TO ADDRESS CHRONIC SCAPULAR DYSKINESIS AND STRUGGLED WITH STIFFNESS AND PAIN FOLLOWING THIS PROCEDURE THOUGHT TO BE RELATED TO EXCESSIVE SCAR TISSUE ADHESIONS. PER CLINICAL REPORT, THE REPORTED EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND UNLIKELY RELATED TO THE PROCEDURE.

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

  MAUDE report 19571248 ↗
• 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 5 MONTHS POST IMPLANTATION OF RIGHT TSA, THE PATIENT PRESENTED WITH SEPTIC LOOSENING. AT FALL 2021 VISIT, SUBJECT SAID HE WAS IN A MVA 2 MONTHS EARLIER AND HAS HAD SEVERE PAIN IN SHOULDER EVER SINCE. X-RAY IMAGES SHOWED LUCENCY AROUND THE GLENOID CAGE & SUPERIOR SCREW. REVISION SURGERY IS TBD. THIS EVENT IS STILL CONSIDERED CONTINUING, AND 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: Bacterial Infection; Implant Pain; Medical device site infection; Pain

  MAUDE report 19481570 ↗
• InjuryMay 7, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Migration; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Migration

  AS REPORTED, THE 74 YEAR OLD FEMALE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2020. THE PATIENT WAS REVISED ON (B)(6) 2024. THE PATIENT EXPERIENCED A SCAPULA FRACTURE AND THE BASEPLATE AND GLENOSPHERE SPUN 180 DEGREES AND WAS UPSIDE DOWN. THE INFERIOR SCREW HAD BROKEN. THERE WAS METALOSIS AS A RESULT OF THE IMPLANT ARTICULATING AT AN ACUTE ANGLE. THE STEM WAS STILL WELL FIXED AND THERE WAS NO PRESENCE OF INFECTION. THE PATIENT IS A RHEUMATOID ARTHRITIS SUFFERER AND THERE WAS SIGNIFICANT RESORBTION OF THE TUBEROSITIES. ALL IMPLANTS WERE REMOVED EXCEPT THE STEM. A NEW ANATOMIC REPLICA PLATE, SCREW AND A CTA HEAD WERE IMPLANTED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT HAS A HEMI ARTHROPLASTY NOW AND SHOULD BE COMFORTABLE. PATIENT RANGE OF MOTION (ROM) AND FUNCTION WILL BE VERY LIMITED HOWEVER. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO IMPLANTS WERE SENT TO PATHOLOGY.

  Patient problems: Bone Fracture(s); Metal Related Pathology

  MAUDE report 19260490 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2023. THE PATIENT PRESENTED ON (B)(6) 2023 WITH A TYPE 2 SCAPULAR SPINE FRACTURE. THE PATIENT NOTICED INCREASED PAIN AFTER A SUDDEN INCREASE IN ACTIVITY TO CLEAN UP AFTER STORM, ACROMION FRACTURE WITH ANGULATION. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. OUTCOME IS CONTINUING. DUE TO CLINICAL STUDY, NO DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: Bone Fracture(s); Pain; Periprosthetic fracture

  MAUDE report 18280344 ↗
• InjuryNov 22, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT RTSA ON (B)(6) 2019. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO GLENOID LOOSENING AND EVIDENCE OF NOTCHING. THERE WAS NO REPORTED BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Joint Impingement

  MAUDE report 18197013 ↗
• InjurySep 8, 2023Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EXACTECH EQUINOXE SHOULDER STUDY, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2020. THE PATIENT PRESENTED ON (B)(6) 2022 WITH ASEPTIC GLENOID LOOSENING AND WAS REVISED TO NON-EXACTECH DEVICES ON (B)(6) 2022. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY RELATED TO THE DEVICE AND PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. OUTCOME: RESOLUTION DATE: (B)(6) 2022.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17711136 ↗
• InjuryFeb 24, 2022Fracture; Fracture

  AS REPORTED, APPROXIMATELY 3 YEARS POST OP THE INITIAL RSTA, THIS (B)(6) Y/O MALE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. PATIENT DOES NOW KNOW WHEN IMPLANT BROKE. THE CAGE OF THE BASEPLATE AND A SCREW BROKE IN THE SCAPULA. BROKEN IMPLANTS WERE REMOVED AND REVISED TO A REVERSE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING.

  Patient problems: Failure of Implant

  MAUDE report 13590310 ↗
• InjuryAug 5, 2019Break

  REVISION DUE TO THE PATIENT¿S GLENOID BREAKING.

  Patient problems: No Code Available

  MAUDE report 8859626 ↗