Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SURGICAL SIMPLEX CEMENT; BONE CEMENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH SURGICAL SIMPLEX CEMENT; BONE CEMENT Back to Search Results
Catalog Number 61910001
Device Problems Use of Device Problem (1670); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/15/2017
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.A supplemental report will be submitted upon completion of the investigation.Review of the batch manufacturing records indicate that packs were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.An x-ray was received and submitted for medical review.The clinician consultant concluded: severe under-sizing of the cement restrictor relative to the diameter of the femoral canal has allowed massive leaking of bone cement past the cement restrictor into the mid femoral canal intramedullary space.The cause of cement leaking past the restrictor is evident because the cement restrictor is largely undersized in both ap and lateral dimension relative to the femoral canal diameter in this area.Theoretically this could adversely influence quality of cementation of the stem although the x-rays do not support this.No revision was required and no adverse effects are to be expected on either short or long term.
 
Event Description
It was inserted the cement into medullary cavity by the revolution.However, the cement did not implanting deep into the medullary space.Update from medical review: severe under sizing of the cement restrictor relative to the diameter of the femoral canal has allowed massive leaking of bone cement past the cement restrictor into the mid femoral canal intramedullary space.
 
Event Description
It was inserted the cement into medullary cavity by the revolution.However, the cement did not implanting deep into the medullary space.Update from medical review: severe under sizing of the cement restrictor relative to the diameter of the femoral canal has allowed massive leaking of bone cement past the cement restrictor into the mid femoral canal intramedullary space.Update event description based on information provided from qara: complaint of cement was early curing, the stem could not progress into the canal, when the original stem could not be inserted, a smaller stem used in the procedure instead.No delay reported.
 
Manufacturer Narrative
An event regarding setting time involving a simplex p cement was reported.The event was not confirmed.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.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 or handbook.A review of the provided medical records and x-rays by a clinical consultant indicated severe under sizing of the cement restrictor relative to the diameter of the femoral canal has allowed massive leaking of bone cement past the cement restrictor into the mid femoral canal intramedullary space.Theoretically this could adversely influence quality of cementation of the stem although the x-rays do not support this.No revision was required and no adverse effects are to be expected on either short or long term.No further investigation for this event is possible at this time.If additional information becomes available this investigation will be reopened.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SURGICAL SIMPLEX CEMENT
Type of Device
BONE CEMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7187156
MDR Text Key97766403
Report Number0002249697-2018-00141
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 05/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/18/2017
Device Catalogue Number61910001
Device Lot NumberJJY025
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/15/2017
Initial Date FDA Received01/12/2018
Supplement Dates Manufacturer Received04/11/2018
Supplement Dates FDA Received05/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-