Revolution 0606565000Recalls & reported problems
Stryker Corporation · Cement Mixing System with MIS Femoral Breakaway Nozzle · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613154169672), received between Jun 7, 2019 and Jan 29, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (3 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
- Delivered as Unsterile Product3
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261796 ↗MalfunctionJul 23, 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 8816170 ↗MalfunctionJun 7, 2019Delivered as Unsterile Product; Delivered as Unsterile Product
THE USER FACILITY REPORTED THAT DEBRIS WAS ON THE OUTSIDE OF THE CEMENT MIXER UPON DELIVERY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8680573 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.