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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX ABC CE MARK 1 PCK; BONE CEMENT
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STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX ABC CE MARK 1 PCK; BONE CEMENT Back to Search Results
Catalog Number 61969001
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/20/2018
Event Type  malfunction  
Manufacturer Narrative
The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.Review of the batch manufacturing records indicates packs were manufactured and accepted into final stock with no relevant reported discrepancies.Lot bfy021 is comprised of a powder batch and liquid batch which were also reviewed and no discrepancies noted.There have been no other events for the reported lot.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
Surgeon used nrg tkr in a patient and informed that our antibiotic simplex bone cement 40gms set in 7 minutes.Usually he uses one packet of cement but as the cement set in 7 minutes from mixing time by the time he applied to patellar component it solidified and had to open a new patella and one more cement packet.This time as he had to only cement the patellar component the cement could be used but the new cement also set in 7 minutes.He told me that lately the working time has reduced from 12 to 9 minutes.
 
Event Description
Surgeon used nrg tkr in a patient and informed that our antibiotic simplex bone cement 40gms set in 7 minutes.Usually he uses one packet of cement but as the cement set in 7 minutes from mixing time by the time he applied to patellar component it solidified and had to open a new patella and one more cement packet.This time as he had to only cement the patellar component the cement could be used but the new cement also set in 7 minutes.He told me that lately the working time has reduced from 12 to 9 minutes.
 
Manufacturer Narrative
An event regarding setting time involving simplex cement was reported.The event was not confirmed.Conclusions: the investigation concluded that the reported setting time issue cannot be confirmed.The mixing properties of the retain and returned samples were tested and show that all required specifications are met.The mixing characteristics and working properties of simplex abc bone cements are influenced primarily by the temperature of the liquid and powder components at the time of mixing and by the temperatures of the utensils with which it contacts during mixing e.G.Mixing bowls, cement introducers etc.Generally, higher temperatures accelerate the polymerization reaction and lower temperatures delay it.Other factors which can affect setting time are mixing technique (speed, use of vacuum, centrifugation), thoroughness of mixing, complete utilization of all of the powder & liquid and care to avoid inclusion of any extraneous material such as blood or sterilization solutions into the mix.Mixing process/technique issues are highlighted in the or handbook.Based on the laboratory results of the samples tested it is not possible to replicate this event.No further investigation for this event is possible at this time.If additional information becomes available this investigation will be reopened.
 
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Brand Name
SIMPLEX ABC CE MARK 1 PCK
Type of Device
BONE CEMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7354594
MDR Text Key103082473
Report Number0002249697-2018-00788
Device Sequence Number1
Product Code LOD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 06/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2019
Device Catalogue Number61969001
Device Lot NumberBFY021
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2018
Date Manufacturer Received05/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age65 YR
Patient Weight85
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