AEQUALIS REVERSED II DWD194Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03700386935923), received between Aug 1, 2016 and Mar 30, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THIS PATIENT HAD MULTIPLE REVISIONS. REVISION OF ALL STRYKER IMPLANTS WAS DONE DUE TO INFECTION, EVERYTHING WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 24710442 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE SECOND REVISION SURGERY THAT OCCURRED ON (B)(6) 2023 FROM RETENTIVE +12 (DWD978) & LATERALISED 29X42MM (DWD194) GLENOSPHERE THEN TO A SPACER (DWD920) AND +6MM INSERT (DWD976) AND ECCENTRIC GLENOSPHERE (DWD195). NO FURTHER INFORMATION WAS PROVIDED. LATER, IT WAS REPORTED DURING THIRD REVISION THAT, BACKGROUND ON THE PATIENT IS THAT HE SADLY HAS AN ALCOHOL PROBLEM HENCE THE MANY FALLS LEADING TO DISLOCATIONS, NOT COMPLIANT WITH REHAB. WITH AN INCREASED RISK OF INFECTION.

  Patient problems: Fall; Insufficient Information; Subluxation

  MAUDE report 24322772 ↗
• InjuryJul 21, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVERSE SHOULDER REPLACEMENT 10 YEARS AGO. ALLEGEDLY, THE PATIENT PRESENTED WITH PAIN AND A REVISION WAS SCHEDULED. DURING THE REVISION THE SITE APPEARED INFECTED. INVESTIGATIONS DONE AND BONE SCAN SHOWED HOT SPOT OVER THE GLENOID WHILE X RAY DEMONSTRATED GLENOID LOOSENING. GLENOID COMPONENT WAS LOOSE AND MEDIALISED AND ONE SCREW HAD BROKEN. GLENOID IMPLANT REMOVED, ALONG WITH THE POLY FROM THE HUMERAL COMPONENT. CULTURES TAKEN. CONVERTED TO A HEMI.

  Patient problems: Implant Pain; Unspecified Infection

  MAUDE report 15079160 ↗
• InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH A PERIPROSTHETIC INFECTION 6 WEEKS AFTER INITIAL SURGERY. RE-OPERATION WITHOUT COMPONENT CHANGE (IRRIGATION AND DEBRIDEMENT, MEDICATION IV DAPTOMYCIN AND NOW CHRONIC SUPPRESSION WITH DOXYCYCLINE)

  Patient problems: Unspecified Infection

  MAUDE report 12305057 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2016. ON (B)(6) 2017, REVISION SURGERY FOR INFECTION WAS PERFORMED (CONVERSION OF THE REVERSE SHOULDER ARTHROPLASTY (RSA) TO HRP. ALL TORNIER COMPONENTS WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 11942297 ↗
• InjurySep 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2020; AN INFECTION WAS CONFIRMED IN THE AFFECTED AREA. (B)(6) 2020: REVISION SURGERY WAS PERFORMED. THE GLENOID SPHERE AND THE INSERT WERE REPLACED TO PREVENT DISLOCATION AND THE SURGERY WAS COMPLETED. WHEN THE EACH IMPLANTS WERE REPLACED, THE GLENOID SPHERE NEWLY USED WAS THE SAME DATA AS LAST TIME, BUT THE INSERT WAS CHANGED TO DWD990 THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 10565768 ↗
• InjurySep 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  GLENOSPHERE HAD DISASSOCIATED FROM THE BASEPLATE POST OP;

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 10546435 ↗
• InjuryMay 10, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE 42 X 29MM TILTED GLENOID SPHERE'S CENTER PIN DID NOT WANT TO LOOSEN UP. MYSELF AS REP TRIED AND WHEN THE SCREW DRIVER SLIPPED I CHANGED THE SCREW DRIVER TIP TO A NEW ONE. THE SURGEON ALSO TRIED TO LOOSEN THE PIN AFTER ME BUT FAILED TO DO SO TOO. UPON INSTRUCTION WE OPENED A SECOND 42 X 29MM TILTED GLENOID SPHERE AND THE SAME THING HAPPENED. THE PIN WAS STUCK AND WE COULD NOT TURN THE CENTER PIN CLOCKWISE OR ANTI-CLOCKWISE. THE SURGERY WAS COMPLETED BY USING A THIRD IMPLANT, A 42 X 29MM ECCENTRIC GLENOID SPHERE. THIS RESULTED IN THE PATIENT'S OPERATING TIME INCREASING WITH AT LEAST 30 MINUTES.

  Patient problems: Failure of Implant

  MAUDE report 8598900 ↗
• InjuryJan 3, 2018Disassembly; Disassembly

  GLENOSPHERE DISASSOCIATED FROM BASEPLATE 4 MONTHS POST-OPERATIVE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7159707 ↗
• MalfunctionJun 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO INSTABILITY/DISLOCATION. GLENOSPHERE WAS REPLACED DURING SURGERY, THE OTHER COMPONENTS REMAINED THE SAME FROM PREVIOUS SURGERY (2ND STAGE OF 2ND REVISION SURGERY SEE MDR # 3000931034-2017-00118, MDR # 3000931034-2017-00119, MDR # 3000931034-2017-00120).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6642975 ↗
• InjuryJan 5, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY / DISLOCATION. POLY INSERT AND GLENOSPHERE WERE SWAPPED OUT, ALL OTHER COMPONENTS REMAINED THE SAME.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6225542 ↗
• InjuryAug 1, 2016Disassembly; Disassembly

  IT WAS REPORTED THAT A GLENOSPHERE DISLOCATED WITHIN 3 WEEKS OF SURGERY. DURING SURGERY NO PROBLEMS, GLENOSPHERE WAS FIXED WELL.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5836162 ↗