AEQUALIS REVERSED II DWD192Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03700386935909), received between Aug 10, 2016 and Nov 18, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2024Unstable; Osseointegration Problem; Unstable; Osseointegration Problem

  PATIENT UNDERWENT RIGHT REVERSE SHOULDER REPLACEMENT. PATIENT INFORMED SURGEON AT THE TIME THAT HER RIGHT (PROSTHETIC) SHOULDER WAS BECOMING MORE PAINFUL OF LATE. X-RAYS / SCANS SHOWED A LOOSE GLENOID COMPONENT. DURING SURGERY OF RIGHT PROSTHETIC SHOULDER YESTERDAY, THICK BLOOD-STAINED FLUID ASPIRATED FROM JOINT - POSSIBLE INFECTED JOINT, ACCORDING TO SURGEON. MULTIPLE TISSUE SAMPLES TAKEN. DECISION MADE TO REMOVE ALL COMPONENTS, EXCEPT THE WELL-FIXED STEM. ALL OTHER COMPONENTS REMOVED. STEM (LEFT INSITU) WAS CONVERTED TO HEMI-ARTHROPLASTY. 2ND STAGE REVISION SURGERY WILL BE PLANNED FOR SOMETIME IN THE FUTURE, WHEN SURGEON DETERMINES SUITABILITY.

  Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection

  MAUDE report 20707964 ↗
• InjuryMay 21, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM.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) 2016 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 19366920 ↗
• InjurySep 18, 2023Migration; Migration

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

  Patient problems: Inadequate Osseointegration

  MAUDE report 17770467 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE CONSULTATION FOR THE CLINICAL REASSESSMENT OF A PAINFUL RIGHT SHOULDER, ABOUT 4 AND A HALF MONTHS FROM THE IMPLANTATION OF A REVERSED TOTAL SHOULDER PROSTHESIS. THE CURRENT EVOLUTION IS MORE RELATED TO A LOW NOISE EVOLUTION INFECTION THAN A PAIN SYNDROME, AS INITIALLY SUSPECTED. THE CONTROL OF THE SCAR OF THE DAY IS INDEED INFLAMMATORY, WITH A SWELLING SUGGESTING POSSIBLE FISTULIZATION OF THE SKIN INFECTION. PRIMARY SURGERY WAS CONDUCTED, 5 MONTHS LATER INFECTION WAS DETECTED. 6 MONTHS AFTER PRIMARY SURGERY THE PATIENT UNDERWENT A REVISION WITH IMPLANT REMOVAL AND ANTIBIOTICS. ONE YEAR POST-OP THE EVENT RESOLVED WITHOUT SEQUELAE.

  Patient problems: Implant Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16600257 ↗
• InjuryAug 24, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT HAD DECREASING RANGE OF MOTION AND WORSENING PAIN DUE TO GLENOID LOOSENING. X-RAYS SHOW LOOSENING OF THE GLENOSPHERE COMPLEX TILTING UPWARDS. REVISION SURGERY WAS RECOMMENDED TO FIX LOOSE COMPONENT. (B)(6).

  Patient problems: Pain

  MAUDE report 7812370 ↗
• InjuryJul 27, 2017Missing Value Reason; Missing Value Reason

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO INSTABILITY / DISLOCATION. PATIENT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6746274 ↗
• InjuryAug 10, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY DISLOCATION. THE IMPLANTED GLENOID SPHERE AND ANOTHER MANUFACTURER'S HUMERAL IMPLANTS WERE REMOVED AND REPLACED WITH NEW COMPONENTS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED FOR THIS PATIENT. PATIENT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5864372 ↗