Equinoxe 300-30-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862515766), received between Feb 24, 2021 and May 20, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Dec 5, 2018Class IITerminated

   Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather than the Equinoxe Preserve Humeral Stem IFU as intended .

   Z-0958-2019 · Root cause: Packaging · Recall details · FDA record ↗

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.

• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL STUDY THAT A REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY THREE (3) MONTHS LATER, ON AN UNKNOWN DATE, THE PATIENT HAD A FRACTURE IN THE PROXIMAL HUMERUS REGION IN THE ABSENCE OF TRAUMA. THE SURGEON NOTED IT IS EXTREMELY UNUSUAL FOLLOWING REVERSE TOTAL SHOULDER ARTHROPLASTY BUT MAY REFLECT TOO GREAT ACTIVE USE OR TOO AGGRESSIVE PHYSICAL THERAPY. MEDICATION WAS PRESCRIBED AND THE PATIENT WAS ADVISED TO STOP SUPERVISED PHYSICAL THERAPY FOR THE NEXT SIX (6) WEEKS, AS WELL AS ANY OVERHEAD STRETCHING EXERCISES. THE PATIENT WAS INSTRUCTED TO DO PENDULUM EXERCISES FOR SIX (6) WEEKS AND THEN RETURN TO THE SURGEON FOR REPEAT EVALUATION AND RADIOGRAPHS. THE PATIENT'S OUTCOME WAS REPORTED AS RESOLVED ON FOLLOW UP VISIT ELEVEN (11) MONTHS POST INITIAL SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Periprosthetic fracture

  MAUDE report 25234470 ↗
• InjuryJun 10, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 5 YEARS AND 8 MONTHS POST THE INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO COMPONENT LOOSENING. THERE WAS SEVERE BONE LOSS. 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: Aseptic loosening; Osteolysis

  MAUDE report 22175101 ↗
• InjuryMay 27, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 4 YEARS AND 2 MONTHS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT COMPLAINED OF PAIN AND WAS REVISED. EVERYTHING WAS LOOSE. 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: Pain

  MAUDE report 22087643 ↗
• InjuryMay 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, APPROXIMATELY 10 MONTHS AND 6 DAYS POST THE INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT CAME IN TO THE CLINIC AND DESCRIBED A POP SENSATION WHEN REACHING BEHIND THEIR BACK. X-RAY SHOWED A DISSOCIATED TRAY. THE TORQUE SCREW MANAGED TO BACK OUT AND THE TRAY DISSOCIATED FROM THE STEM. A REVISION WAS PERFORMED AND THE STEM WAS EXTRACTED AND A NEW ONE IMPLANTED. A +10 TRAY WAS USED, AND A 38MM POLY. 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: Insufficient Information

  MAUDE report 21994768 ↗
• InjuryJan 9, 2025Migration; Migration

  APPROXIMATELY 2 YEARS AND 8 DAYS POST INITIAL RIGHT SHOULDER TOTAL ARTHROPLASTY, THE PATIENT STATED HE SLEPT ON HIS SHOULDER A LITTLE WEIRD, IT FELT OFF AND COMPLAINED OF A GRINDING FEELING. PATIENT WENT TO DOCTOR'S OFFICE FOR EVALUATION AND X-RAYS WERE TAKEN. IT IS OBSERVED THAT THE POLY LOOKS TO HAVE DISSOCIATED FROM THE TRAY. PATIENT WAS REVISED WITH ADDITIONAL NOTES FROM THE DOCTOR STATING: "FOUND THAT THE POLY HAD IN FACT DISSOCIATED FROM THE TRAY AND WAS SUPERIOR TO THE JOINT. THERE IS SOME WEAR OBSERVED ON THE POLY. DOCTOR THEN REMOVED THE TORQUE SCREW. HE NOTED THAT THE TRAY AND STEM HAD SUBSIDED A DECENT AMOUNT. WHEN HE WENT TO DISENGAGE THE TRAY FROM THE STEM, THEN ENTIRE CONSTRUCT CAME RIGHT OUT OF THE HUMERUS. SOME STEM LOOSENING CAN BE OBSERVED ON THE X-RAYS. DOCTOR DEBRIDED THE HUMERUS AND BROACHED UP ON THE STEM. HE THEN WENT ON TO REMOVE THE GLENOSPHERE AND LOCKING SCREW." THERE WERE NO REPORTED BREAKAGES OR SURGICAL DELAY/PROLONGATION AND THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED FOR INVESTIGAT

  Patient problems: Insufficient Information

  MAUDE report 21116073 ↗
• InjuryOct 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 5 YEAR(S), 3 MONTH(S) AND 21 DAY(S) POST-OPERATIVE OF A LEFT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. ALSO REPORTED WAS FAILED TSA, INCREASED PAIN WITH ADLS, ASEPTIC GLENOID AND HUMERAL LOOSENING, BREAKAGE OF COMPONENTS, MIGRATION OF ANCHOR OR SCREW. APPROXIMATELY 3.5 YEARS EARLIER, THE PATIENT EXPERIENCED SHOULDER PAIN THE RADIATES FROM THE NECK DOWN TO THE ELBOW. SHOULDER HURTS WITH ACTIVITY. HAS DDD (DEGENERATIVE DISC DISEASE) OF C-SPINE ON RADIOGRAPHS. THE PATIENT WAS RECOMMENDED A FOLLOW-UP APPOINTMENT VIA TELEMEDICINE VISIT TO DISCUSS REVISION PROCEDURE. THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 20510359 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: EQUINOXE SHOULDER STUDY. SUBJECT: (B)(6). AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6)2018 AND PRESENTED ON AND UNKNOWN DATE IN 2021 WITH PAIN - UNEXPLAINED; SUPERIOR SHOULDER PAIN WITHOUT EVIDENCE OF FRACTURE. INCREASED PAIN WITHOUT INJURY DURING THE SUMMER OF 2021. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. PATIENT ADVISED TO TAKE ACTION OF IMMOBILIZATION FOR 6 WEEKS. THE OUTCOME OF THIS EVENT IS RESOLVED ON 14-JUN-2022. HEIGHT: 63 IN / BMI: 26. PREVIOUS SURGERY ON INVOLVED SHOULDER? YES, ON (B)(6) 2008; ROTATOR CUFF REPAIR. DIAGNOSIS: ROTATOR CUFF TEAR. OTHER DIAGNOSIS: FUNCTIONAL PSEUDOPARALYSIS. COMORBIDITIES: HYPOTHYROIDISM. 300-30-08 - EQUINOXE PRESERVE STEM 8MM: 5569575. 510K: K162726. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY.

  Patient problems: Pain

  MAUDE report 18481214 ↗
• InjuryNov 22, 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) 2021. THE PATIENT PRESENTED ON 26-OCT-2023 WITH DEEP INFECTION. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. OUTCOME WAS RESOLVED ON 26-OCT-2023 WITH MEDICAL INTERVENTION - COMPLETION OF 1 YEAR OF ABX WITH NO RECURRENT INFECTION.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 18196997 ↗
• InjuryJul 30, 2021Fracture; Fracture

  AS REPORTED, THE PATIENT SUFFERED A (B)(6) FEMALE PATIENT EXPERIENCED A SCAPULAR SPINE FRACTURE. THE PATIENT FELT A PAINFUL POP IN RT SHOULDER AND HAS NOT SEEN IMPROVEMENT WITH CONSERVATIVE MANAGEMENT. OPEN REDUCTION INTERNAL FIXATION OF THE SCAPULAR SPINE. OUTCOME IS NOTED AS RESOLVED (B)(6) 2021 IN THE STUDY DATABASE. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY RELATED TO DEVICES OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Bone Fracture(s)

  MAUDE report 12251955 ↗
• InjuryApr 30, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 9 MOS. POSTOP THE INITIAL L TSA AND 8MM SHORT STEM THAT WAS IMPLANTED IN THIS (B)(6) Y/O PATIENT, CAME LOOSE. THE SURGEON THINKS THE PATIENT'S STEM BECAME LOOSE WHEN HE STARTED PLAYING GOLF. WE REPLACED THE SHORT STEM WITH A STANDARD SIZE STEM AND A LATERALIZED GLENOSPHERE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS NOT RETURNING DUE TO FACILITY POLICY.

  Patient problems: Failure of Implant

  MAUDE report 11751696 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, DURING THE INITIAL IMPLANTATION OF THE RIGHT TSA IN THE (B)(6) Y/O MALE PATIENT, EXPERIENCED A NON-DISPLACED HUMERAL FRACTURE OF THE GREATER TUBEROSITY OCCURRED. IT WAS STABLE. NO FIXATION REQUIRED. THE PATIENT HAS A HISTORY OF MULTIPLE SHOULDER ARTHROSCOPIES AND OSTEOARTHRITIS. THE CASE REPORT FORM INDICATES THIS EVENT IS NOT RELATED TO DEVICES AND DEFINITELY RELATED PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Bone Fracture(s)

  MAUDE report 11373823 ↗