Equinoxe 320-15-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10885862186690), received between Dec 20, 2022 and Jan 27, 2026 — classified as 13 injuries.

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2026Structural Problem

  IT WAS REPORTED A PATIENT WHO HAD A RTSA, UNDERWENT AN EXPLANT PROCEDURE. ALL IMPLANTS WERE REMOVED DUE TO INFECTION FOLLOWING A LONG-STANDING TRAUMA, (FRACTURE DISLOCATION OVER A YEAR PRIOR), WHICH BECAME INFECTED. THE PATIENT WILL FINISH A COURSE OF ANTIBIOTICS AND THEN LIKELY UNDERGO A REVISION TO HRP. THEY ARE AWAITING A CT AS THERE IS ALSO BONE LOSS PRESENT ON THE 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. NO X-RAYS WERE PROVIDED. AWAITING APPROVAL FOR RELEASE OF REVISED IMPLANTS. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 6 REPORTS FOR THIS EVENT.

  Patient problems: Bone Fracture(s); Joint Dislocation; Unspecified Infection

  MAUDE report 24196042 ↗
• InjuryFeb 5, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 79 YO FEMALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED IN (B)(6) 2022, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025, APPROXIMATELY 2 YEARS 1 MONTH POST THE INITIAL PROCEDURE. THE PATIENT¿S BASEPLATE HAD COME LOOSE. 2 OUT OF THE 3 SCREWS HAD BROKEN. THE SURGEON COULD NOT REVISE TO A REVERSE BECAUSE THE AREA WAS TOO SMALL. THE SURGEON PACKED THE GLENOID WITH BONE GRAFT AND HE PUT IN A BIG CTA. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THERE WERE NO X-RAYS AVAILABLE. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISPOSED OF BY THE HOSPITAL. NO DEVICE IMAGES WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 21316268 ↗
• InjuryOct 28, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 5 YEAR(S), 4 MONTH(S) AND 27 DAY(S) POST-OPERATIVE OF A RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING - SEVERE OSTEOLYSIS BEHIND BASEPLATE. IT WAS FURTHER REPORTED THAT THIS PRODUCED PERSISTENT / SIGNIFICANT DISABILITY AND MEDICAL / SURGICAL INTERVENTION WAS NECESSARY. THE PATIENT UNDERWENT STANDARD REVERSE REVISION WITH THE REMOVAL OF THE TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, GLENOSPHERE LOCKING SCREW, GLENOID BASEPLATE, AND COMPRESSION SCREW / LOCKING CAP. THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING, AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE(S) AND DEFINITELY RELATED TO THE PROCEDURE.

  Patient problems: Osteolysis

  MAUDE report 20547367 ↗
• InjuryAug 23, 2024Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 1 YEAR(S), 7 MONTH(S) AND 11 DAY(S) POST-OPERATIVE OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING; GRADUAL INCREASE IN PAIN OVER LAST 6 MONTHS-LOOSE STILTED BASEPLATE SUPPORTED WITH MONTAGE. THE PATIENT UNDERWENT STANDARD REVERSE REVISION SURGERY AND WAS REVISED TO A SPACER. 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: Inadequate Osseointegration; Pain

  MAUDE report 20047955 ↗
• InjuryJun 6, 2024Structural Problem; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Structural Problem; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 4 YEAR(S) AND 9 MONTH(S) POST IMPLANTATION OF A RIGHT TSA, THE PATIENT PRESENTED WITH INFECTION. THE PATIENT HAD RTSA WITH LOOSE GLENOSPHERE + METAGLENE COMPONENT WITHOUT BROKEN HARDWARE AND SCAPULAR NOTCHING. PLAN FOR REVISION WITH ANTIBIOTIC SPACER. THE PATIENT UNDERWENT A STANDARD REVERSE REVISION IN EARLY 2019 FOLLOWED WITH ANTIBIOTIC SPACER PROCEDURE LATER THAT YEAR. IMPLANTATION OF ANTIBIOTIC DELIVERY SYSTEM DUE TO POSITIVE MRSA SCREEN. PATIENT HAS CLEARED INFECTION AND DESIRES CONVERSION BACK TO A REVERSE TSA. THE CLINICAL REPORT INDICATES THAT THE EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND UNLIKELY RELATED TO THE PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arthritis; Bone Notching; Failure of Implant; Unspecified Infection

  MAUDE report 19481376 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 3.5 YEARS POST INITIAL RIGHT TSA, THE MALE PATIENT HAD A REVISION DUE TO INFECTION. ALL IMPLANTS WERE REMOVED. 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 UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE DEVICES WERE DISCARDED AT THE HOSPITAL.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 19388867 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 76-YEAR-OLD NON-HISPANIC WHITE FEMALE HAD A RIGHT TSA ON (B)(6) 2022. THE PATIENT PRESENT WITH OTHER SCAPULAR FRACTURE ON (B)(6) 2023. THE PATIENT HAD TO USE HER RIGHT ARM FOR TRANSFER AFTER POSTOP ANKLE FRACTURE AND DEVELOPED A GLENOID (NON-DISPLACED). NO ACTION WAS TAKEN FOR THIS EVENT AND THE OUTCOME IS CONSIDERED RESOLVED ON (B)(6) 2023. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE 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 19217937 ↗
• InjuryJan 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 67 YO MALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2022, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 1 YEAR 8 MONTHS POST THE INITIAL PROCEDURE. THE REPORT INDICATED THE GLENOID WAS LOOSE AND INFECTION WAS SUSPECTED. THE PATIENT WAS REVISED TO A 300-10-15 EQUINOXE REPLICATOR PLATE 1.5MM O/S, 300-20-02 EQUINOXE SQUARE TORQUE DEFINE SCREW, AND 310-03-53 EQUINOXE HUMERAL HEAD EXPANDED 53MM. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. NO X RAYS OR PATIENT HISTORY WAS ABLE TO BE OBTAINED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICES ARE RETURNING FOR ANALYSIS DUE TO THE HOSPITAL POLICY. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 18493419 ↗
• InjuryNov 29, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN IMPACTING THE GLENOID PLATE THE GLENOID FRACTURED. THE SURGEON DECIDED TO REPLACE THE GLENOID PLATE WITH ONE WITH A LONGER CAGE TO GET BETTER FIXATION. THE SUP/POST AUGMENT PROVIDED BETTER FIXATION. THERE WAS A 15-30 MIN DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Limb Fracture

  MAUDE report 18229606 ↗
• InjuryNov 22, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE PATIENT HAD AN INITIAL TSA ON (B)(6) 2020. THE PATIENT PRESENTED ON 28-JUN-2023 WITH ASEPTIC GLENOID LOOSENING - BREAKAGE OF COMPONENTS LEADING TO GLENOID LOOSENING. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICE AND/OR TO PROCEDURE. OUTCOME IS CONTINUING WITH INSTRUCTIONS TO WATCH & WAIT, STOKE PATIENT WAITING MEDICAL CLEARANCE.

  Patient problems: Aseptic loosening; Failure of Implant

  MAUDE report 18196994 ↗
• InjuryAug 7, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA CLINICAL STUDY, THAT APPROXIMATELY 18 MONTHS POSTOP THE INITIAL IMPLANT, THIS 73 YO MALE PATIENT WAS EXPERIENCING SEVERE PAIN FOR 2 MONTHS. X-RAY RESULT SHOWS AN ASEPTIC GLENOID LOOSENING. PATIENT WAS PRESCRIBED SOFT REHABILITATION INVOLVING SHOULDER AND SPINE AS HE SUFFERS FROM CERVICAL SPINE PATHOLOGY WHICH COULD EXPLAIN THE PAIN. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING. THE CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. DEVICES WILL NOT BE RETURNED.

  Patient problems: Aseptic loosening; Implant Pain; Pain

  MAUDE report 17475891 ↗
• InjuryApr 18, 2023Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 73 YO FEMALE PATIENT WAS EXPERIENCING ASEPTIC GLENOID LOOSENING RESULTING IN GLENOID FRACTURE OR OSTEOLYSIS. THE DATE OF EVENT ONSET IT (B)(6) 2023. THE PATIENT¿S STANDARD REVERSE SHOULDER SYSTEM WAS REVISED TO HEMIARTHROPLASTY. THE OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2023.

  Patient problems: Aseptic loosening; Bone Fracture(s); Osteolysis; Periprosthetic fracture

  MAUDE report 16762320 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 2.5 YEARS POST INITIAL TSA, THE 82 Y/O OBESE MALE PATIENT EXPERIENCED DEEP INFECTION. PATIENT HAD ANTERIOR SHOULDER PAIN WITHOUT INJURY FOR 6 MONTHS. THE EVENT IS STILL ONGOING. NO ADDITIONAL INFORMATION.

  Patient problems: Bacterial Infection; Pain; Unspecified Infection

  MAUDE report 16018610 ↗