AEQUALIS REVERSED DWB935Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700386916144), received between Feb 21, 2018 and Jun 14, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT AND EXPERIENCED NEW ONSET OF SHOULDER PAIN AFTER THAT. THE X-RAYS SHOWED A SUBSIDENCE OF HUMERAL COMPONENT. THE PATIENT HAD THE INSERT AND GLENOSPHERE REVISED.

  Patient problems: Implant Pain

  MAUDE report 14684935 ↗
• InjuryFeb 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT WOKE UP WITH ANTERIOR DISLOCATION -TREATED WITH CLOSED REDUCTION ON (B)(6) 2015. THIS PATIENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY/DISLOCATION 2 MONTHS POST-OPERATIVE. PATIENT ID : (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7285266 ↗
• InjuryFeb 21, 2018Disassembly; Loosening of Implant Not Related to Bone-Ingrowth; Disassembly; Loosening of Implant Not Related to Bone-Ingrowth

  "2014 AEQUALIS REVERSED OPERATION ON (B)(6) 2018: THE PATIENT FELL WHICH MAY HAVE CAUSED LOOSENING OF GLENOID SPHERE AND BASEPLATE. AS A LITTLE SWELLING AND PUS WERE SEEN IN THE INSERTION SITE, THE SURGEON DECIDED TO REMOVE THE IMPLANTS. ON (B)(6) 2018: AS THE INFECTION WAS ONLY THE SURFACE OF THE SKIN, ONLY THE GLENOID SPHERE, INSERT AND BASEPLATE WERE REMOVED AND A HEAD WAS IMPLANTED. COMMENT FROM SURGEON: IF INFECTION WAS VERY SERIOUS, I WAS GOING TO REMOVE ALL THE IMPLANTS BUT IT WAS NOT SO SERIOUS, SO I JUST LEFT THE STEM AND IMPLANTED A HEAD. THIS PATIENT SEEMED TO HAVE SOME KIND OF INFECTION AFTER THE SURGERY 4 YEARS AGO BUT IT DID NOT BECOME SERIOUS. SO, THIS COMPONENT LOOSENING CAN BE THE CAUSE OF THIS INCIDENT."

  Patient problems: Fall; Unspecified Infection

  MAUDE report 7285262 ↗