AEQUALIS REVERSED II DWE830Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03700386952739), received between Nov 21, 2017 and Mar 14, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Break” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD REVISION SURGERY DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18903047 ↗
• InjuryDec 29, 2023Osseointegration Problem; Osseointegration Problem

  TORNIER SHOULDER OUTCOMES STUDY - SHOUT (B)(6). LOOSENING OF THE GLENOID COMPONENT BECAUSE OF A FALL DOWN OF THE PATIENT, GENERATING A GLENOID FRACTURE. DATE OF EXPLANT: (B)(6) 2019. RESOLVED WITHOUT SEQUELAE: (B)(6) 2019. UPDATE: ACCORDING TO THE ATTACHED REPORTS AND AN HCP REVIEW, ONE OF THE 32MM SCREWS WAS BROKEN. IT IS UNKNOWN WHICH ONE.

  Patient problems: Bone Fracture(s); Fall; Inadequate Osseointegration

  MAUDE report 18419281 ↗
• InjurySep 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT IN THE TORNIER SHOULDER OUTCOMES STUDY DEVELOPED AN INFECTION, SPECIFICALLY P. ACNES. THIS INFECTION WAS TREATED WITH A 6-WEEK COURSE OF INTRAVENOUS (IV) ANTIBIOTICS. FOLLOWING THE IV ANTIBIOTICS, THE PATIENT WAS STARTED ON ORAL SUPPRESSION THERAPY WITH SEQUELAE.

  Patient problems: Bacterial Infection

  MAUDE report 17762353 ↗
• InjuryMay 24, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE REV II BASEPLATE, SCREWS, AND GLENOSPHERE WERE REMOVED BECAUSE OF NOTCHING AND LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16997515 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REPLACEMENT SURGERY. POST-OP THE PATIENT REPORTS HAVING SEVERE PAIN. PATIENT ID: (B)(6).

  Patient problems: Implant Pain

  MAUDE report 13651232 ↗
• InjuryMar 21, 2019Break; Break

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO GLENOID IMPLANT BREAKAGE 6 MONTHS POST-OPERATIVE. SUBJECT ID: (B)(6)."

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8439244 ↗
• InjuryMay 4, 2018Break; Break

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR GLENOID IMPLANT BREAKAGE, 4 YEARS POST-OPERATIVE. PATIENT ID: (B)(6)."

  Patient problems: Failure of Implant

  MAUDE report 7486530 ↗
• InjuryNov 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO INFECTION, 20 MONTHS POST-OP. PATIENT ID: (B)(6)".

  Patient problems: Unspecified Infection

  MAUDE report 7048086 ↗