AEQUALIS REVERSED II DWE730Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03700386952661), received between Sep 6, 2018 and Dec 31, 2024 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT (B)(6) SHOUT - TORNIER SHOULDER OUTCOMES STUDY PAIN IN THE SHOULDER DUE TO A FALL."

  Patient problems: Fall; Implant Pain

  MAUDE report 21045853 ↗
• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT 008-00078 SHOUT - TORNIER SHOULDER OUTCOMES STUDY PATIENT REPORTS PAIN AND SWELLING."

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 21045849 ↗
• InjuryJun 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT REQUIRED REVISION SURGERY AFTER DISLODGMENT AND POSSIBLE INFECTION.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 19521280 ↗
• InjuryJun 5, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  AS REPORTED: "INSTABILITY/DISLOCATION. REVISION SURGERY (LEFT SHOULDER). HUMERAL SIDE COMPONENTS RETAINED FROM FIRST SURGERY". SERIES OF EVENTS BELOW: (B)(6) 2016: AEQUALIS ASCEND FLEX HUMERAL COMPONENTS / AEQUALIS REVERSED II GLENOID COMPONENTS (WITH A THREADED POST BASEPLATE) IMPLANTED (REVERSED CONFIGURATION). (B)(6) 2018: PATIENT FALL FROM BED AT HOME ("NO FRACTURE OR PROTHESIS DISLOCATION") *. (B)(6) 2018: INDICATION: MEDICAL EVALUATION OF PAIN FOLLOWING TRAUMA EVENT. DIFFUSE BONE DEMINERALIZATION. A DISLOCATION BACKWARDS AND DOWNWARDS OF THE SHOULDER PROSTHESIS. ABSENCE OF TRAUMATIC BONE LESION CLEARLY DEMONSTRATED (NUMEROUS ARTI-FACTS LINKED TO THE PROSTHESIS. (B)(6) 2018: INDICATION: MEDICAL EVALUATION AFTER SURGERY. DISLOCATION OF THE TOTAL LEFT REVERSED SHOULDER WITH A SMALL FRACTURE OF THE GLENOID INFERIOR SCREW. (B)(6) 2018: REVISION SURGERY WITH A REVERSED SHOULDER ARTHROPLASTY CONFIGURATION. -EXPLANTED: GLENOID COMPONENTS -RETAINED: HUMERAL COMPONENTS. -IMPLANTED: NEW BASEPLATE (WITH LONG POST BASEPLATE) AND SPHERE WITH GRAFT. -SLING, IMMOBILIZATION.

  Patient problems: Implant Pain; Joint Dislocation; Joint Laxity

  MAUDE report 19467895 ↗
• InjuryJun 6, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT REVERSE SHOULDER IMPLANTED IN APPROXIMATELY 2019. THE GLENOID BASEPLATE COMPONENT OF THE SYSTEM BECAME LOOSE OVER TIME. THE GLENOID COMPONENT OF THE SYSTEM WAS REMOVED WITHOUT ISSUE AND THE IMPLANT WAS CONVERTED TO A HEMI SHOULDER WITH THE POLY REMOVED ON THE HUMERAL SIDE AND REPLACED WITH A CONVERTOR AND HUMERAL HEAD.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14606044 ↗
• MalfunctionFeb 25, 2022Unintended Ejection; Unintended Ejection

  THE OLIVE BROKE FROM BASEPLATE.

  Patient problems: Failure of Implant

  MAUDE report 13606700 ↗
• InjuryJun 3, 2021Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  CASE BOOKED FOR A REVISION. REVERSED THREADED POST BASEPLATE PUT IN, IN (B)(6) 2019 NEEDS TO BE REVISED, PROBABLY USING A PERFORM REVERSE, ANOTHER REVERSED THREADED POST OR CONVERT TO A HEMI. BOOKING FROM SURGEONS ROOMS, AFTER IMPLANT TO PATIENT (2019) UPDATE (B)(6) 2021 : REVISION DUE TO SCREW SNAPPING AND BASEPLATE LOOSENING.

  Patient problems: Failure of Implant

  MAUDE report 11933829 ↗
• InjuryAug 28, 2020Break; Loosening of Implant Not Related to Bone-Ingrowth; Break; Loosening of Implant Not Related to Bone-Ingrowth

  VISIT DATE ON (B)(6) 2018 (ONSET DATE OF ADVERSE EVENT: (B)(6) 2017). POST-OPERATIVE COMPLICATION: HUMERAL FRACTURE / INJURY (TRAUMATIC). TRAUMA ON LEFT SHOULDER : 1 SCREW BROKEN AND LOOSENING OF GLENOÏD. NO SURGICAL PROCEDURE AT THAT TIME. (B)(6) 2018: REVISION SURGERY FOR IMPLANT BREAKAGE ON THE GLENOID SIDE.

  Patient problems: Bone Fracture(s); Failure of Implant; Inadequate Osseointegration

  MAUDE report 10464814 ↗
• InjuryApr 9, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING/LYSIS 3 YEARS AFTER PRIMARY SURGERY. SUBJECT ID: (B)(6)"

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8495325 ↗
• InjurySep 6, 2018Break; Break

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR IMPLANT BREAKAGE (GLENOID) 2 YEARS POST-OPERATIVE. STEM AND INSERT REMAINED IMPLANTED FROM PREVIOUS SURGERY. ONLY THE BASEPLATE AND GLENOID SPHERE WERE CHANGED. PATIENT ID : (B)(6)".

  Patient problems: Failure of Implant

  MAUDE report 7852641 ↗