AEQUALIS REVERSED II DWD191Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03700386935893), received between Aug 11, 2016 and Mar 14, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 16, 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 18903037 ↗
• InjuryMar 23, 2022Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO DISLOCATION AFTER A FALL; IT WAS NOT RELATED TO ANY DEVICE. THERE WAS ALSO LOOSENING OF THE PROSTHESIS, ROTATOR CUFF INSUFFICIENCY , POLY WEAR, AND THE PATIENT HAD PAIN. INSERT WAS REPLACED TO 42+9A; THE TRAY WAS REPLACED TO A HIGH+0.

  Patient problems: Failure of Implant; Implant Pain; Joint Dislocation; Joint Laxity

  MAUDE report 13861952 ↗
• InjuryMar 12, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY/DISLOCATION. STRYKER - TORNIER SAS AEQUALIS REVERSED II GLENOID SPHERE AND ZIMMER REVERSE CUP WERE REMOVED. ALL OTHER COMPONENTS RETAINED.

  Patient problems: Implant Pain; Joint Dislocation

  MAUDE report 13743330 ↗
• InjuryDec 20, 2021Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT PATIENT (B)(6) UNDERWENT A REVISION SURGERY SEVEN YEARS AFTER PRIMARY STUDY SURGERY DUE TO INSTABILITY/DISLOCATION. "THERE WAS ALSO LOOSENING OF THE PROSTHESIS, ROTATOR CUFF INSUFFICIENCY, POLY WEAR, AND THE PATIENT HAD PAIN." "AEQUALIS REVERSED II GLENOSPHERE WAS REMOVED, AS WELL AS AEQUALIS ASCEND FLEX REVERSED INSERT AND TRAY. INSERT WAS REPLACED TO 42+9A; THE TRAY WAS REPLACED TO A HIGH+0."" THE AEQUALIS ASCEND FLEX STEM AND THE AEQUALIS REVERSED II BASEPLATE WERE RETAINED FROM PREVIOUS SURGERY.

  Patient problems: Implant Pain; Muscle Weakness/Atrophy

  MAUDE report 13049295 ↗
• InjuryJun 17, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE GLENOIDSPHERE COULD NOT BE IMPLANTED AS THE CENTRAL SCREW WAS BLOCKED. ANOTHER GLENOID SPHERE WAS USED AND THE SURGERY WAS COMPLETED WITH A DELAY.

  Patient problems: Awareness During Anesthesia; Failure of Implant

  MAUDE report 10161693 ↗
• InjuryDec 19, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR INSTABILITY/DISLOCATION 4 MONTHS POST-OPERATIVE. PATIENT ID : (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7128304 ↗
• InjuryJun 12, 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. INSERT AND GLENOSPHERE WERE REPLACED, ALL OTHER COMPONENTS REMAINED THE SAME FROM PREVIOUS SURGERY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6633021 ↗
• InjuryAug 11, 2016Adverse 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 LOOSENING/LYSIS. GLENOSPHERE AND BASEPLATE WERE REMOVED AND REPLACED WITH NEW COMPONENTS FROM ANOTHER MANUFACTURER. PATIENT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5867910 ↗