MAUDE Adverse Event Report: STRYKER CORPORATION REVOLUTION; MIXER, CEMENT, FOR CLINICAL USE

Model Number 0606563000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2020

Event Type  malfunction  

Event Description

The stryker revolution cement mixing system with femoral breakaway nozzle (model #: 0606-563-000, lot/batch #: 19348012, exp.Date: 12/01/2020) malfunctioned during a left mediolateral knee arthroplasty.When opened and attached to the pnuematic hose system (vacuum pump), the internal mixing devices disengaged when the vacuum tube was connected to the system.A second device was opened, and the same issue persisted.Multiple cement packets were wasted in the process of troubleshooting the device until the old cement system with the hand mixer was opened to finish the procedure.

• Brand Name: REVOLUTION
• Type of Device: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER CORPORATION; 6201 south sprinkle road; portage MI 49002
• MDR Report Key: 10282294
• MDR Text Key: 199071303
• Report Number: 10282294
• Device Sequence Number: 1
• Product Code: JDZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0606563000
• Device Catalogue Number: 0606563000
• Device Lot Number: 19348012
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18980 DA