AEQUALIS REVERSED II DWD988Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03700386932731), received between Nov 21, 2017 and Aug 1, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Disassembly” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT WAS REVISED DUE TO AN INFECTION. ALL THE IMPLANTS WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22683963 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY INCLUDING THE REMOVAL OF GLENOID IMPLANTS AND POLY LINER IN NEEDED DUE TO INFECTION. IT WAS ALSO REPORTED BY THE FACILITY THAT THE INFECTION HAD NOTHING TO DO WITH THE PRODUCT OR STERILITY OF THE PRODUCT.

  Patient problems: Unspecified Infection

  MAUDE report 22373913 ↗
• InjuryApr 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO WEAR ON THE GLENOID INFERIOR ALONG WITH THE PATIENT HAVING PAIN.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 19037092 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO AN INFECTION 12 MONTHS POST-OP. THE METAL DEVICES WERE REMOVED AND A COMPETITOR'S CEMENT SPACER WAS INSERTED.

  Patient problems: Unspecified Infection

  MAUDE report 15043707 ↗
• InjuryApr 9, 2020Adverse 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 A PERIPROSTHETIC FRACTURE 8 YEARS AFTER PREVIOUS SURGERY. PATIENT ID: (B)(6).

  Patient problems: Bone Fracture(s)

  MAUDE report 9942955 ↗
• InjuryNov 21, 2017Disassembly; Disassembly

  (B)(6) 2017: INITIAL RSA SURGERY WAS DONE.(B)(6) , 2017: GLENOID SPHERE DISLOCATION WAS FOUND. / (B)(6) , 2017: GLENOID SPHERE AND INSERT WERE REPLACED.

  Patient problems: Failure of Implant; Patient Problem/Medical Problem

  MAUDE report 7048091 ↗
• InjuryNov 21, 2017Disassembly; Disassembly

  (B)(6) 2017: INITIAL RSA SURGERY WAS DONE. / (B)(6) 2017: GLENOID SPHERE DISLOCATION WAS FOUND. /(B)(6) 2017: GLENOID SPHERE AND INSERT WERE REPLACED.

  Patient problems: Failure of Implant; Patient Problem/Medical Problem

  MAUDE report 7048080 ↗