AEQUALIS REVERSED II DWH901Recalls & reported problems
Tornier · Class 2 · Implant
All models of AEQUALIS REVERSED II (46)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700386955013), received between Apr 22, 2024 and Apr 22, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bacterial Infection1
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "PATIENT UNDERWENT LEFT PRIMARY SHOULDER REPLACEMENT ON (B)(6) 2020. PATIENT PRESENTED TO SURGEON IN 2023, WITH A HISTORY OF A PAINFUL LEFT SHOULDER, AND A DISCHARGING SINUS (LEFT AXILLA). SWABS GREW THE BACTERIA C.ACNES. PLAN: REMOVE ALL PROSTHESIS (1ST STAGE) / INSERT AN ANTIBIOTIC CEMENT SPACER; RETURN IN SEVERAL MONTHS, WHEN CLINICAL MARKERS INDICATE INFECTION RESOLVED, AND IMPLANT A NEW PROSTHETIC LEFT SHOULDER JOINT(2ND STAGE). TODAY, ALL PROSTHESIS REMOVED, DISCARDED. MULTIPLE SPECIMENS TAKEN FOR PATHOLOGY."
Patient problems: Bacterial Infection; Implant Pain
MAUDE report 19153484 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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