AEQUALIS REVERSED DWB996Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03700386916571), received between Dec 27, 2018 and May 21, 2025 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  1ST STAGE REVISION OF AEQUALIS REVERSED II HUMERUS/ GLENOID DUE TO LONG STANDING INFECTION, ACQUIRED 18 MONTHS POST INDEX SURGERY. SURGEON SAID IT WAS NOT PRODUCT FAULT. CAUSE OF INFECTION NOT RELATED TO PRODUCT. SIMPLY NOTIFYING THAT THESE PROSTHESIS WERE EXPLANTED. NATURE OF INFECTION AND BUG UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 22064046 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 21882202 ↗
• MalfunctionJul 8, 2024Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  AS REPORTED: "THE DELIVERY OF LOANER KITS # 2090431704 TOOK PLACE WITHOUT ANY PROBLEM NOTIFICATION - COMPLETE IMPLANTS & INSTRUMENTS. HOWEVER, AFTER CHECKING THE KIT ON SITE, IT WAS FOUND THAT THE DWB996 IMPLANT WAS MISSING AND THE DWD082 IMPLANT WAS INCLUDED TWICE. AS A RESULT, A COMPROMISED SOLUTION HAD TO BE FOUND DURING THE OPERATION WHERE DWB996 WAS ACTUALLY REQUIRED (BUT NOT AVAILABLE) WITH THE USE OF A DIFFERENT INLAY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697405 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A WOUND WASHOUT AND CHANGE OF POLY DUE TO INFECTION. THERE WAS A REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 15584300 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A WOUND WASHOUT AND CHANGE OF POLY DUE TO INFECTION. THERE WAS A REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 15584216 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD A WOUND WASHOUT AND THE POLY WAS CHANGED DUE TO AN INFECTION. THERE WAS A REVISION PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection

  MAUDE report 15579206 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVERSE SHOULDER REPLACEMENT ON (B)(6) 2019. PATIENT HAS HAD A LONG STANDING HISTORY OF WOUND INFECTION, WHICH HAS REQUIRED MULTIPLE RE-OPERATIONS FOR WOUND WASHOUT AND CHANGE OF POLY. SURGERY YESTERDAY ALSO RESULTED IN EXCHANGE OF HUMERAL POLY AND ALSO THE GLENOSPHERE ON THIS OCCASION, WITH COPIOUS LAVAGE. MULTIPLE TISSUE SPECIMENS TAKEN.

  Patient problems: Post Operative Wound Infection

  MAUDE report 15533188 ↗
• InjuryMay 16, 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 PROCEDURE TO REVERSE TOTAL SHOULDER REPLACEMENT DUE TO INFECTION. THE WOUND WAS NOTICED NEXT TO THE INCISION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 14406896 ↗
• InjuryDec 27, 2018Material Erosion; Material Erosion

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO HETEROTOPIC OSSIFICATION AND HUMERAL COMPONENT WEAR, 8 YEARS POST-OPERATIVE. PATIENT ID: (B)(6).

  Patient problems: Extraskeletal ossification; Patient Problem/Medical Problem

  MAUDE report 8199070 ↗