Aequalis™ Ascend™ Flex DWF612BRecalls & reported problems
Tornier · Class 2 · Implant
All models of Aequalis Ascend Flex (30)
Data updated Oct 16, 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 03700386944789), received between Nov 13, 2019 and Nov 13, 2019 — 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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AFTER THE INITIAL ASCEND FLEX REVERSED SURGERY ON (B)(6) 2017,THIS PATIENT HAD A REVISION SURGERY TWICE FOR DISLOCATION REASONS. THE FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2017, AND THE INSERT WAS REPLACED. THE SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2017, AND ALL IMPLANTS WERE REPLACED (REPORTS MDR # 3000931034-2017-00148 AND # 3000931034-2017-00149). AT THIS TIME, INFECTION OF THE AFFECTED AREA WAS ALSO FOUND. ON (B)(6) 2019, THIS PATIENT FELL DOWN AND AROUND THE DISTAL PART OF THE IMPLANTED STEM WAS FRACTURED. A THIRD REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 FOR INFECTION: REMOVAL OF THE STEM, CLEANING, AND INSERTION OF A CEMENT MOLD.
Patient problems: Unspecified Infection
MAUDE report 9318750 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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