AEQUALIS REVERSED DWD054Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03700386931666), received between Jan 3, 2017 and May 20, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM.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 (B)(6)2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2018 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: STAGE 1 OF 2 STAGE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 19354096 ↗
• InjuryMay 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS DRIVING HER CAR WHEN SHE SUDDENLY FELT A 'KNACK'  FOLLOWED  BY AN IMMEDIATELY PAIN. XRAY SHOWED A DISENGAGEMENT OF THE REVERSED HEMI ADAPTER OF THE METAPHYSIAL COMPONENT. REVISION SURGERY PERFORMED ON (B)(6) 2020.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 10086730 ↗
• InjuryOct 4, 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 PAIN 3 YEARS POST-OPERATIVE. (B)(6)".

  Patient problems: Pain

  MAUDE report 7933627 ↗
• InjuryAug 20, 2018Use of Device Problem; Use of Device Problem

  TORQUE WAS APPLIED TO THE NUT PART WHEN ATTACHING THE NUT OF THE CONVERSION ADAPTER, SO THE HUMERUS BROKE THE BONE TRUNK FRACTURE. SINCE IT WAS AN OPERATION OF THE REVISION, THE SURGEON PREPARED A PLATE AND A CABLE, AND PERFORMED OSTEOSYNTHESIS WITH THIS IMPLANT. ABOUT 2 HOURS OF OPERATIVE LENGTHENING.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7797148 ↗
• InjuryJan 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016: DURING SURGERY, GLENOID WAS FRACTURED. STEM AND HEAD WERE PLACED AND PHYSICIAN DECIDED TO WAIT ABOUT 6 MONTHS. ON (B)(6) 2016: WHEN THE PHYSICIAN REMOVED THE IMPLANTS TO REPLACE THEM ALL WITH COMPETITORS PRODUCTS, METALLOSIS WAS OBSERVED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6218597 ↗