AEQUALIS REVERSED FRACTURE DWD922Recalls & reported problems
Tornier · Class 2 · Implant
All models of AEQUALIS REVERSED FRACTURE (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700386931901), received between Feb 25, 2022 and Jun 23, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (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.
Reports received per month
Most reported problems
Device problems
- Defective Component1
- Device Damaged Prior to Receipt by User1
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 23, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
DURING A REVISION SURGERY, THE SURGEON WANTED TO INSERT A LARGE HEAD AND WE DISCOVERED THAT THE HEMI ADAPTER (DWD922) WAS NOT AVAILABLE, ALTHOUGH IT HAD BEEN REQUESTED / ORDERED. AN ALTERNATIVE APPROACH HAD TO BE FOUND DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22311004 ↗MalfunctionFeb 25, 2022Defective Component; Defective Component
DURING THE SURGICAL INTERVENTION OF THE FRACTURE SHOULDER HEMIPROTHESIS SYSTEM, THE DOCTOR REQUESTS A HEMI PROSTHESIS ADAPTER ((B)(4)). IT HAS TWO PIECES: A SCREW AND A PLATAFORM WHICH FIT TO THE HUMERAL STEM. THE PROCEDURE WAS MADE FOLLOW THE INSTRUCTIONS AND GUIDES GIVEN FOR ITS CORRECT IMPLANTATION, BUT WHEN THE DOCTOR TRIES TO ADJUST THE SCREW TO THE HUMERAL STEM IT DOES NOT ADJUST PROPERLY, BECAUSE THE DIAMETER OF THE SCREW IS GREATER THAN THE STEM.
Patient problems: Failure of Implant
MAUDE report 13606771 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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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