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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P-JAPANESE TWIN PACK; BONE CEMENT
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STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P-JAPANESE TWIN PACK; BONE CEMENT Back to Search Results
Catalog Number 61910002
Device Problem Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/17/2018
Event Type  Injury  
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
 
Event Description
Bha, backward approach, using exeter a case of young surgeon's first surgery.It means that it cured in about 4 minutes from the cement stirring.When young surgeon tried to fill cement into the marrow, it has already been cured and we have abandoned filling.(fast setting).In the facility, the cement is stored in cold storage.The agitation speed was one revolution per second (acm use) negative pressure was in the proper range.Therefore older surgeon's new cement and acm to install the implant.However, when surgeon agitated the cement, the condition of the cement felt a sense of discomfort for.As the young surgeon cement hardened, because the cement was filled at a relatively early stage after stirring for the second time, it is said that the feeling of discomfort with regard to the setting time is not felt.
 
Event Description
Bha, backward approach, using exeter a case of young surgeon's first surgery.It means that it cured in about 4 minutes from the cement stirring.When young surgeon tried to fill cement into the marrow, it has already been cured and we have abandoned filling.(fast setting).In the facility, the cement is stored in cold storage.The agitation speed was one revolution per second (acm use) negative pressure was in the proper range.Therefore older surgeon's new cement and acm to install the implant.However, when surgeon agitated the cement, the condition of the cement felt a sense of discomfort for.As the young surgeon cement hardened, because the cement was filled at a relatively early stage after stirring for the second time, it is said that the feeling of discomfort with regard to the setting time is not felt.
 
Manufacturer Narrative
An event regarding (fast) setting time of the bone cement mix involving simplex p cement was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection and functional testing was completed on the three retained samples tested from the reported lot.The results were satisfactory and within specification.Medical records received and evaluation: not performed as no medical records were provided.Device history review: indicated that all product was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been one other similar event for the reported lot.Conclusions: the investigation concluded that the reported setting time issue cannot be duplicated.The mixing properties of the retained samples of the reported lot code were tested and show that all required specifications are met.The mixing characteristics and working properties of surgical simplex 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 ifu.Based on the laboratory results of the retain samples 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 P-JAPANESE TWIN PACK
Type of Device
BONE CEMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8071354
MDR Text Key127157040
Report Number0002249697-2018-03728
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 01/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/30/2023
Device Catalogue Number61910002
Device Lot NumberJEZ028
Was Device Available for Evaluation? No
Date Manufacturer Received12/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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