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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P - CE ABC FD 10-PK; IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P - CE ABC FD 10-PK; IMPLANT Back to Search Results
Catalog Number 61969010
Device Problems Difficult to Remove (1528); Use of Device Problem (1670); Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 06/23/2014
Event Type  Injury  
Event Description
It was reported that during a primary thr on the (b)(6) 2014, the cement set too quickly and prior to the surgeon completing the implantation of the prosthesis.The customer further reported that attempts were made to remove the set cement from the patient using normal chisels and hand tools, but the surgeon was unable to remove all the cement, so the procedure was abandoned and the patient was closed.The customer reported that the procedure was rescheduled for 3 days later on the (b)(6) 2014.The customer reports that the 3 day delay occurred because theatre needed to hire in an oscar ultrasonic cement removal system which is not a standard piece of equipment at the hospital to remove the cement.The customer further reported that this second procedure was completed successfully.The customer reported that they were uncertain if cement from the same batch was used in the second procedure.The customer reported that at the time the original procedure was being undertaken temperatures in theatre were fluctuating from 16°c to 25°c and that there had been problems with the heating system in theatre, which staff was attempting to bring under control.The customer reports that prior to the procedure, the cement had been stored in the fridge.The customer was unable to confirm the temperature in theatre at the point the cement was being mixed.The customer reported that a cement gun was used to mix the cement and that the guns are routinely kept in the storeroom and taken out of the storeroom when setting up for surgery.The customer reported that they assume that the gun would be at the same temperature as the theatre at the point, the cement was mixed.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.The subject device is not cleared for sale in the u.S., but a similar device is commercially available in the u.S.
 
Manufacturer Narrative
An event regarding setting time involving simplex abc bone cement was not confirmed.Device evaluation and results: visual inspection and functional testing was completed on three of the returned samples of the reported lot.The results were satisfactory and within specification.Medical records received and evaluation: no medical records were received or were relevant to the investigation of this event.Device history review: bmr review for the specified lot indicates that the devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: chr review determined that there was one similar event reported for the referenced lot.This other event is from the same hospital and remains to be investigated.The investigation concluded that the reported setting time issue cannot be confirmed.The mixing properties of the returned samples of the reported lot code 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 returned samples it is not possible to replicate this event.No further investigation for this event is possible at this time.
 
Event Description
It was reported that during a primary thr on the (b)(6) 2014, the cement set too quickly and prior to the surgeon completing the implantation of the prosthesis.The customer further reported that attempts were made to remove the set cement from the patient using normal chisels and hand tools, but the surgeon was unable to remove all the cement, so the procedure was abandoned and the patient was closed.The customer reported that the procedure was rescheduled for 3 days later on the (b)(6) 2014.The customer reports that the 3 day delay occurred because theatre needed to hire in an oscar ultrasonic cement removal system which is not a standard piece of equipment at the hospital to remove the cement.The customer further reported that this second procedure was completed successfully.The customer reported that they were uncertain if cement from the same batch was used in the second procedure.The customer reported that at the time the original procedure was being undertaken temperatures in theatre were fluctuating from 16°c to 25°c and that there had been problems with the heating system in theatre, which staff was attempting to bring under control.The customer reports that prior to the procedure, the cement had been stored in the fridge.The customer was unable to confirm the temperature in theatre at the point the cement was being mixed.The customer reported that a cement gun was used to mix the cement and that the guns are routinely kept in the storeroom and taken out of the storeroom when setting up for surgery.The customer reported that they assume that the gun would be at the same temperature as the theatre at the point the cement was mixed.
 
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Brand Name
SIMPLEX P - CE ABC FD 10-PK
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
william hanna
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4006490
MDR Text Key4710927
Report Number0002249697-2014-03085
Device Sequence Number1
Product Code LOD
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 07/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2015
Device Catalogue Number61969010
Device Lot NumberBBV008
Other Device ID NumberSTERILE LOT 131176
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/15/2014
Initial Date FDA Received08/13/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/25/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/05/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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