Equinoxe 320-40-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862535047), received between Mar 1, 2022 and May 15, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 6, 2024Open, Classified

   The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

   Z-1420-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT REVERSE SHOULDER REPLACEMENT ON AN UNKNOWN DATE. SUBSEQUENTLY, THE POLYETHYLENE LINER AND HUMERAL TRAY DISASSOCIATED. AS A RESULT, THE PATIENT UNDERWENT A LEFT SHOULDER REVISION AN UNKNOWN AMOUNT OF TIME AFTER INITIAL SURGERY. NO FURTHER PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION AVAILABLE. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22029594 ↗
• InjuryNov 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, APPROXIMATELY 2 YEARS AND 11 MONTHS POST INITIAL RIGHT TOTAL KNEE ARTHROPLASTY (TKA), THE PATIENT WAS TRYING TO START HIS CHAINSAW AND THE POLYETHYLENE DISASSOCIATED FROM THE HUMERAL TRAY. IT WAS NOTED THAT THE PATIENT WAS REGULARLY DOING MANUAL INTENSIVE LABOR. THE PATIENT UNDERWENT REVISION AT WHICH TIME THE SURGEON REMOVED THE GLENOSPHERE LINER AND HUMERAL TRAY AND THEY WERE REPLACED WITH A 40MM +4 GLENOSPHERE AND A 0+ HUMERAL TRAY, AND 2.5+MM, 40MM POLYETHYLENE. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20668775 ↗
• InjurySep 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  APPROXIMATELY 3 YEAR(S), 4 MONTH(S) AND 20 DAY(S) POST-OPERATIVE OF A RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED DISASSOCIATION OF POLYETHYLENE. SUBJECT NOTED PAIN WHEN REACHING. X-RAY SHOWED POLY DISASSOCIATION. THE PATIENT UNDERWENT STANDARD REVERSE WITH PRESERVE STEM REVISION, IN WHICH THE TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, AND GLENOSPHERE LOCKING SCREW WERE REMOVED. THE OUTCOME IS CONSIDERED RESOLVED AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND DEFINITELY RELATED TO THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 20286322 ↗
• InjuryMay 20, 2024Device 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 BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 1 YEAR AND 1 MONTH POST RIGHT TSA IMPLANTATION, THE 53 Y/O MALE PATIENT PRESENTED WITH A DISLOCATION. "HE WAS DOING WELL UNTIL LATE 2022 WHEN FOLLOWING A VIGOROUS WORKOUT IN THE GYM HE SUSTAINED A DISLOCATION OF THE RIGHT SHOULDER WHILE TURNING OVER IN BED. HE REQUIRED AN EMERGENCY ROOM REDUCTION AT A LOCAL HOSPITAL AND HAS BEEN FINE SINCE THAT TIME. HE HAD NO SYMPTOMS PRIOR TO THIS INSTABILITY EPISODE." THE ACTION TAKEN WAS CLOSED REDUCTION IN ER. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CLINICAL STUDY REPORT INDICATES THIS EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 19356507 ↗
• InjuryMar 11, 2024Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 72 YO FEMALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2023, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 2 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO INFECTION. THE SURGEON PERFORMED A WASHOUT AND REPLACED THE LINER. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE REP WAS UNABLE TO OBTAIN ANY DEVICE IMAGES OR X-RAYS. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DISPOSED OF BY THE HOSPITAL. NO FURTHER INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 18882554 ↗
• InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY EQUINOXE SHOULDER STUDY, APPROXIMATELY 2 MONTHS POST OP THE INITIAL TSA, THIS (B)(6) MALE PATIENT EXPERIENCED REDNESS AND SWELLING TO HIS PROXIMAL INFECTION. HE ALSO HAD SURGICAL REMOVAL OF A HAEMATOMA. 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 problems: Bacterial Infection

  MAUDE report 14632636 ↗
• InjuryMar 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS REVISION WAS FOUND DURING THE INVESTIGATION OF (B)(4). REASON FOR THE REVISION IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13634062 ↗