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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, ANTIBIOTIC
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STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P-JAPANESE TWIN PACK; BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number 61910002
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2019
Event Type  malfunction  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.Device not returned.
 
Event Description
It was reported that when the cement was mixed, it was harden earlier than usual during tka surgery.Therefore the cement was changed the new same one and the operation was continued.Cement was keep in a refrigerator in hospital from one day before the operation and it was removed from the refrigerator 10 minutes before use.
 
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 have been no other similar events 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.
 
Event Description
It was reported that when the cement was mixed, it was harden earlier than usual during tka surgery.Therefore the cement was changed the new same one and the operation was continued.Cement was keep in a refrigerator in hospital from one day before the operation and it was removed from the refrigerator 10 minutes before use.
 
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Brand Name
SIMPLEX P-JAPANESE TWIN PACK
Type of Device
BONE CEMENT, ANTIBIOTIC
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8817249
MDR Text Key151901401
Report Number0002249697-2019-02632
Device Sequence Number1
Product Code MBB
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 10/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2022
Device Catalogue Number61910002
Device Lot NumberJDZ027
Was Device Available for Evaluation? No
Date Manufacturer Received09/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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