AEQUALIS REVERSED DWD067Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03700386928239), received between Aug 21, 2017 and Oct 26, 2023 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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.

• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS COMPLEX REGIONAL PAIN SYNDROME. PATIENT STARTED EXPERIENCING SYMPTOMS 2 WEEKS POST OPERATIVELY. PATIENT HAS BEEN GOING TO PHYSIO THERAPY TO MANAGE SYMPTOMS. EVENT IS ONGOING.

  Patient problems: Implant Pain

  MAUDE report 18012239 ↗
• InjurySep 18, 2023Migration; Migration

  IN THE TORNIER SHOULDER OUTCOMES STUDY , A RADIOGRAPH REPORT NOTED A NOTCH EXTENDING TO A LOWER SCREW. THE ISSUE WAS MANAGED WITH CONSERVATIVE CARE. THERE HAVE BEEN NO ADDITIONAL FOLLOW-UP VISITS FOR THIS PATIENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17770466 ↗
• InjuryFeb 25, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  "IT WAS REPORTED THAT A PATIENT HAD AN HETEROTOPIC OSSIFICATION OF THE GLENOID. PATIENT ID: (B)(6)".

  Patient problems: Extraskeletal ossification

  MAUDE report 13607115 ↗
• InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A POST-OPERATIVE COMPLICATION: DEEP INFECTION. "PATIENT COMPLAINING OF ONGOING PAIN- CT ASPIRATION WAS POSITIVE FOR C ACNES" PATIENT WILL SCHEDULE REVISION SURGERY. (THE ADVERSE EVENT WAS IDENTIFIED AS NOT RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE SURGICAL PROCEDURE).

  Patient problems: Bacterial Infection; Implant Pain

  MAUDE report 13475995 ↗
• 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 12304950 ↗
• 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 11942486 ↗
• InjuryMay 15, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  "IT WAS REPORTED THAT A PATIENT HAD A GLENOID COMPONENT LOOSENING, AS X-RAYS OF RIGHT SHOULDER REVEALED INCLINATION OF THE BASEPLATE AND SHOWS GRAFT RESORPTION, 4 YEARS AFTER PRIMARY SURGERY. (FURTHER TO PREVIOUS TOTAL SHOULDER ARTHROPLASTY WITH BIO-RSA BONE GRAFTING ON (B)(6) 2015). SUBJECT ID: (B)(6)"

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8611453 ↗
• MalfunctionJan 11, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING/LYSIS 3 YEARS POST-OPERATIVE, WITH ONE BROKEN MULTIDIRECTIONAL SCREW. SUBJECT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8239721 ↗
• InjuryNov 6, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT HAD AN INSTABILITY/DISLOCATION (4 EPISODES OF ANTERIOR DISLOCATIONS OVER THE PAST YEAR) ; THE DISLOCATIONS SEEM TO HAPPEN WITH RAPID/DYNAMIC EXTERNAL ROTATION. PATIENT ID: (B)(4).

  Patient problems: Joint Dislocation

  MAUDE report 8041663 ↗
• InjuryJul 17, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR LOOSENING/LYSIS AT 10 MONTHS POST-OPERATIVE. PATIENT ID : (B)(6)".

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7694205 ↗
• InjuryJan 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "IT WAS REPORTED THAT A PATIENT HAD A GLENOID BASEPLATE INSTABILITY AND ANTERIOR BROKEN SCREW, WITH PAIN, 11 MONTHS POST-OPERATIVE. PATIENT ID : (B)(6). SUBJECT SCHEDULED TO HAVE REVISION TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2018.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7193174 ↗
• InjuryAug 21, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT IS FACING AN INSTABILITY-DISLOCATION. PATIENT DISLOCATED SHOULDER AND HAS HAD ISSUES WITH INSTABILITY SINCE. X-RAYS SHOW BROKEN INFERIOR SCREW ON GLENOID. PATIENT WILL UNDERGO A REVISION SURGERY TO FIX INSTABILITY ISSUES. PATIENT ID : (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6806691 ↗