Revolution 0606593000Recalls & reported problems
Stryker Corporation · Cement Mixing System with Femoral Breakaway Nozzle and Advanced Femoral Canal Pressurizer (Medium) · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540447913), received between Oct 28, 2019 and May 19, 2023 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture2
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2023Fracture; Fracture
THE USER FACILITY REPORTED THAT THE BOTTOM OF DEVICE CANISTER HAS BROKEN ENTERING THE HOLDER WITH NO EXCESS FORCE DURING A PROCEDURE. FEMORAL CANAL HAD TO BE SCRAPED OUT WITH A CURETTE TO REMOVE THE CEMENT THAT WENT INTO THE FEMORAL CANAL AND RE-PREPPED READY FOR THE NEXT LOT OF CEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16961480 ↗InjuryMay 19, 2023Fracture; Fracture
THE USER FACILITY REPORTED THAT THE BOTTOM OF DEVICE CANISTER HAS BROKEN ENTERING THE HOLDER WITH NO EXCESS FORCE DURING A PROCEDURE. FEMORAL CANAL HAD TO BE SCRAPED OUT WITH A CURETTE TO REMOVE THE CEMENT THAT WENT INTO THE FEMORAL CANAL AND RE-PREPPED READY FOR THE NEXT LOT OF CEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16961478 ↗MalfunctionOct 28, 2019Delivered as Unsterile Product; Delivered as Unsterile Product
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9245091 ↗
Other MIXER, CEMENT, FOR CLINICAL USE devices
- SMARTSET 5450-35-500Depuy (Ireland) · MIXER, CEMENT, FOR CLINICAL USE2 deaths965 reports
- NA 5049-11Zimmer, Inc. · MIXER, CEMENT, FOR CLINICAL USE1 recall389 reports
- ACM 0306573000Stryker Corporation · MIXER, CEMENT, FOR CLINICAL USE2 recalls9 reports
- NA 0206530000Stryker Corporation · MIXER, CEMENT, FOR CLINICAL USE2 recalls2 reports
- NA 0206512000Stryker Corporation · MIXER, CEMENT, FOR CLINICAL USE2 recalls2 reports
- ACM 0306563000Stryker Corporation · MIXER, CEMENT, FOR CLINICAL USE1 recall44 reports
- AutoPlex, VertaPlex 0607687000Stryker Corporation · MIXER, CEMENT, FOR CLINICAL USE1 recall4 reports
- Revolution 0606573000Stryker Corporation · MIXER, CEMENT, FOR CLINICAL USE1 recall2 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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