MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO REVOLUTION CMS W/ FEMORAL BREAKAWAY NOZZLE; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number 0606563000

Device Problem Biocompatibility (2886)

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

Event Date 04/18/2018

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure at the user facility, there was black residue observed in the cement.There was no medical intervention or adverse consequences reported.

Event Description

It was reported that during a surgical procedure at the user facility, there was black residue observed in the cement.There was no medical intervention or adverse consequences reported.

Manufacturer Narrative

The device was not returned for evaluation; therefore, a root cause could not be determined for the event.

• Brand Name: REVOLUTION CMS W/ FEMORAL BREAKAWAY NOZZLE
• Type of Device: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; highway #3, km 130.2; kalamazoo MI 49001
• MDR Report Key: 7515324
• MDR Text Key: 108359840
• Report Number: 0001811755-2018-00987
• Device Sequence Number: 1
• Product Code: JDZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/10/2018

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 Operator: Health Professional
• Device Catalogue Number: 0606563000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 06/13/2018
• Supplement Dates FDA Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1