AEQUALIS REVERSED II DWH905Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700386955099), received between Sep 17, 2019 and Mar 18, 2025 — classified as 4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS CONTINUED TO EXPERIENCE LAXITY, OCCASIONAL DISLOCATIONS OF HER AFFECTED SHOULDER JOINT, INCLUDING PAIN, POOR RANGE OF MOTION. SURGEON DECIDED DURING SURGERY TO AGAIN INCREASE GLENOSPHERE DIAMETER AND INCREASE HUMERAL REVERSE TRAY, AND AGAIN IMPLANT A RETENTIVE POLY INSERT. PROSTHESIS IMPLANTED, SHOULDER JOINT REDUCED AND FOUND TO BE STABLE THROUGH RANGE OF MOTION.

  Patient problems: Joint Dislocation; Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 21633275 ↗
• InjuryMay 3, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVERSE SHOULDER REPLACEMENT ON (B)(6) 2021. RECENTLY, THE PATIENT EXPERIENCED INSTABILITY OF THIS PROSTHETIC JOINT. TWICE DISLOCATED IN RECENT FORTNIGHT. SURGEON EXAMINED SHOULDER / MANIPULATION UNDER ANESTHETIC - DEMONSTRATED INSTABILITY. RADIOGRAPHICALLY, THE PROSTHESIS APPEARED WELL POSITIONED.

  Patient problems: Failure of Implant

  MAUDE report 14271699 ↗
• InjuryMay 3, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVERSE SHOULDER REPLACEMENT ON (B)(6) 2021. RECENTLY, THE PATIENT EXPERIENCED INSTABILITY OF THIS PROSTHETIC JOINT. SURGEON EXAMINED SHOULDER / MANIPULATION UNDER ANESTHETIC - DEMONSTRATED INSTABILITY. RADIOGRAPHICALLY, THE PROSTHESIS APPEARED WELL POSITIONED. THE PHYSICIAN THEN OPENED THE SHOULDER - SURGEON REMOVED POLY (6MM REVERSED INSERT, DWF391C), 0MM REVERSED TRAY (DWF510) AND 39MM LAT GLENOSPHERE (DWH905). IMPLANTED A 42MM GLENOSPHERE, +6MM REVERSED TRAY AND AN INSERT.

  Patient problems: Failure of Implant

  MAUDE report 14270259 ↗
• InjurySep 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT UNDERWENT INITIAL RSA ON (B)(6) 2017. THE IMPLANTS USED WERE ASCEND FLEX STD PTC HUMERAL STEM (DWF603B), REVERSE INSERT (DWF362B), REVERSE TRAY (DWF520), REVERSED II DIA. 25 PRESS FIT POST BASE PLATE (DWD170) AND REV. II GLENOID SPHERE DIA. 25 BASE PLATE (DWD180). ON (B)(6) 2017, A DISLOCATION OCCURRED AND REVISION SURGERY WAS PERFORMED. DURING THIS SURGERY, TRAY (DWF520), INSERT (DWF391B), AND SPHERE (DWH905) WERE NEWLY USED. IN 2019 (NO DATE), DISLOCATION OCCURRED AGAIN AND MANUAL REDUCTION WAS PERFORMED, BUT A REVISION SURGERY WAS TO BE PERFORMED AGAIN. ON (B)(6) 2019, REVISION SURGERY WAS PERFORMED: ASCEND FLEX: LONG PTC HUMERAL STEM 4B 132.5 ° 104MM (DWF614B), REVERSED INSERT 42MM (+) 9 B-12.5 (DWF425B), REV. II GLENOID SPHERE DIA. 25 BASEPLATE DIA. 42MM 10 TILTED SPHERE (DWD184), ASCEND FLEX REVERSED TRAY (+) 0 1.5MM (DWF510) WERE NEWLY REPLACED.

  Patient problems: Joint Dislocation

  MAUDE report 9079529 ↗