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AEQUALIS PRESS-FIT DWB723Recalls & reported problems

Tornier · Class 2 · Implant

All models of AEQUALIS PRESS-FIT (13)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700386915789), received between Dec 22, 2016 and Sep 5, 2018 — classified as 3 injuries.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem3

Patient problems

  • Patient Problem/Medical Problem3
  • Pain1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR IMPLANT BREAKAGE (GLENOID IMPLANT) WITH PAIN (GLENOID WEAR, GLENOID IMPLANT BREAKAGE, ROTATOR CUFF INSUFFICIENCY, GLENOID BONE LOSS WERE ALL LISTED AS REASONS FOR REVISION. (B)(6).

    Patient problems: Pain; Patient Problem/Medical Problem

    MAUDE report 7845530 ↗
  • InjuryJan 3, 2018Adverse 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 LOOSENING-LYSIS 9 YEARS POST-OP. PATIENT ID : (B)(6)".

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 7159705 ↗
  • InjuryDec 22, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY AT 8 YEARS POST-OPERATIVE DUE TO LOOSENING/LYSIS. CONVERSION INTO RSA.

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 6197853 ↗

Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices

All PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices →

Sources and updates

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