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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO REVOLUTION CMS W/BREAKAWAY; MIXER, CEMENT FOR CLINICAL USE
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STRYKER INSTRUMENTS-PUERTO RICO REVOLUTION CMS W/BREAKAWAY; MIXER, CEMENT FOR CLINICAL USE Back to Search Results
Catalog Number 0606563000
Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Patient Problem Cardiac Arrest (1762)
Event Date 10/26/2014
Event Type  malfunction  
Event Description
It was reported that the revolution cement mixing system was being used in a total hip procedure when the cement leaked out of the sides of the device and would not go through the nozzle as expected.A back up device was prepared resulting in a delay around thirty minutes.The patient suffered a cardiac arrest during this time.The procedure was completed successfully with no further issues.
 
Event Description
It was reported that the revolution cement mixing system was being used in a total hip procedure when the cement leaked out of the sides of the device and would not go through the nozzle as expected.A back up device was prepared resulting in a delay around thirty minutes.The patient suffered a cardiac arrest during this time.The procedure was completed successfully with no further issues.
 
Manufacturer Narrative
A follow up report will be filed after the device is received and the quality investigation has been completed.Not yet received by manufacturer.
 
Manufacturer Narrative
The reported condition (cement leakage) could not be confirmed since the alleged affected unit was not returned to manufacturer for evaluation.In addition, evaluation of the returned new/unopened unit from the same reported product/lot did not replicate the reported failure.
 
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Brand Name
REVOLUTION CMS W/BREAKAWAY
Type of Device
MIXER, CEMENT FOR CLINICAL USE
Manufacturer (Section D)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 0061 5
Manufacturer (Section G)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 0061 5
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key4273282
MDR Text Key5007071
Report Number0001811755-2014-04258
Device Sequence Number1
Product Code JDZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0606563000
Device Lot Number14251012
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received12/08/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/18/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
REVOLUTION CMS W/BREAKAWAY
Patient Outcome(s) Required Intervention;
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