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

Model Number 0606553000

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2022

Event Type  malfunction  

Event Description

While mixing cement for a total joint replacement, the stryker revolution mixing device broke at the beginning of the mixing (ref# 0606-553-000, lot# 21312012, exp 11/01/2022).

• Brand Name: REVOLUTION
• Type of Device: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 13994421
• MDR Text Key: 288484233
• Report Number: 13994421
• 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: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 0606553000
• Device Catalogue Number: 0606553000
• Device Lot Number: 21312012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Female