Aequalis™ Ascend™ Flex DWF607BRecalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700386944666), received between Sep 4, 2018 and Feb 25, 2022 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (2 reports).
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
- Device Contaminated During Manufacture or Shipping2
- Adverse Event Without Identified Device or Use Problem1
- Patient-Device Incompatibility1
Patient problems
- Patient Problem/Medical Problem2
- Bone Fracture(s)1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY FOR SUSPICION OF INFECTION NOT YET CONFIRMED. THE SURGEON REMOVED EVERYTHING EXCEPT BASEPLATE (AFRAID TO BREAK EVERYTHING BECAUSE EXCELLENT BITE).
Patient problems: Unspecified Infection
MAUDE report 13606993 ↗InjuryJul 8, 2021Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT PATIENT WITH AN ASCEND FLEX REVERSED IMPLANT HAD A TRAUMATIC INCIDENT WHICH RESULTS IN A PERIPROSTHETIC FRACTURE OF THE AEQUALIS ASCEND FLEX STEM. AFTER SEEING THE X-RAY SURGEON THOUGHT MAYBE THE STEM WAS IMPLANTED TOO BIG, SO THE FRACTURE COULD EASILY OCCUR.
Patient problems: Bone Fracture(s)
MAUDE report 12140325 ↗MalfunctionSep 4, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
DIFFERENT STEMS AND ALL OF THEM HAD A WHITE PAINT LIKE SUBSTANCE ON THEM. THE ISSUE OCCURRED IN SURGERY, THE PATIENT WAS UNDER ANESTHESIA AND THERE WAS AN ADDITIONAL DELAY OF 30-40 MIN.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7841860 ↗MalfunctionSep 4, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
DIFFERENT STEMS AND ALL OF THEM HAD A WHITE PAINT LIKE SUBSTANCE ON THEM. THE ISSUE OCCURRED IN SURGERY, THE PATIENT WAS UNDER ANESTHESIA AND THERE WAS AN ADDITIONAL DELAY OF 30-40 MIN.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7841854 ↗
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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