AEQUALIS REVERSED DWB994Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03700386916557), received between Mar 24, 2017 and Mar 27, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2024Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 18987418 ↗
• InjuryOct 10, 2023Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2012- (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2020 A PATIENT REQUIRED REVISION SURGERY DUE UNEXPLAINED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE : SINGLE STAGE REVISION.

  Patient problems: Implant Pain

  MAUDE report 17908322 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT REVERSE SHOULDER REPLACEMENT, IN 2017. RECENTLY THE PATIENT HAD DISCHARGING SINUS, OVER PROSTHETIC JOINT. SURGEON DECIDED TO REMOVE ANY LOOSE PROSTHESIS. MULTIPLE SEROUS AND TISSUE SPECIMENS TAKEN FROM RIGHT PROSTHETIC SHOULDER JOINT. HUMERAL COMPONENT, THOUGH VERY WELL FIXED, WAS REMOVED. GLENOSPHERE REMOVED - SPECIMENS TAKEN OF "JELLY-LIKE" MATERIAL BEHIND THE GLENOSPHERE. GLENOID BASEPLATE LEFT INSITU, AS VERY WELL FIXED. COPIOUS LAVAGE. ANTIBIOTIC LADEN CEMENT SPACER PLACED IN JOINT SPACE, AND WOUND CLOSED. THE SURGEON PRESCRIBED THE PATIENT 2 WEEKS OF IV ANTIBIOTICS. THE PATIENT WILL THEN UNDERGO A 2ND STAGE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 16784881 ↗
• InjuryMay 18, 2018Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2015: INITIAL RSA SURGERY. ON (B)(6) 2015: OBSERVED BONE RESORPTION BY NOTCHING IN X-RAY AT 6 MONTHS CHECK. ON (B)(6) 2016: SEEMS THE BONE RESORPTION HAS STOPPED. ON (B)(6) 2018: GLENOID COMPONENT ELIMINATION. BONE GRAFTING.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7525301 ↗
• 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 7285260 ↗
• InjuryMar 24, 2017Adverse Event Without Identified Device or Use Problem; Missing Value Reason; Adverse Event Without Identified Device or Use Problem; Missing Value Reason

  THE PATIENT COMPLAINED PAIN 16 MONTHS AFTER THE OPERATION AND THE PATIENT WAS TREATED WITH INTRA-ARTICULAR CLEANSING AND ANTIBIOTICS FOR 6 MONTHS BUT SINCE THERE WAS NO IMPROVEMENT, ALL THE DEVICES WERE REMOVED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 6432115 ↗