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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_SIMPLEX P TOBRA; BONE CEMENT
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_SIMPLEX P TOBRA; BONE CEMENT Back to Search Results
Catalog Number UNK_LIM
Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)
Patient Problem Cardiac Arrest (1762)
Event Date 05/12/2023
Event Type  Death  
Manufacturer Narrative
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.The following devices were also listed in this report: simplex p tobra; it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
 
Event Description
The following occurred during a right hemi hip procedure using a cemented stem: after preparing the cement, the nozzle spun off of the cement gun.Surgeon was able to get the nozzle back on and injected cement (rep roughly estimates this took approximately from 30 seconds to 2 minutes, but acknowledges that this was not timed).A size 5 accolade c stem was implanted and was sitting approximately 2 cm proud (per the rep, this was due to the cement having set.There is no allegation that the cement set faster than it should have, but that the delay due to the nozzle issue contributed to the cement being set).As the rep went to get cement removal tools, the surgeon had somehow gotten the stem removed.Some, but not all of the cement was removed using the cement removal tools, and surgeon decided to cement in implant a size 2 accolade c stem into the remaining, originally injected and set cement.Once implanted, stem was sitting approximately 1cm proud.The stem was removed, the patient then developed an unspecified cardiac issue (rep left the o.R.To allow hospital staff to address the issue).The patient was closed without a stem being implanted.At some point after this (either the same day or the next day), the patient died.From the start of the nozzle issue to the cardiac issue, approximately 60 minutes had elapsed.Rep confirmed that no further information will be released by the hospital or surgeon.
 
Event Description
The following occurred during a right hemi hip procedure using a cemented stem: after preparing the cement, the nozzle spun off of the cement gun.Surgeon was able to get the nozzle back on and injected cement (rep roughly estimates this took approximately from 30 seconds to 2 minutes, but acknowledges that this was not timed).A size 5 accolade c stem was implanted and was sitting approximately 2 cm proud (per the rep, this was due to the cement having set.There is no allegation that the cement set faster than it should have, but that the delay due to the nozzle issue contributed to the cement being set).As the rep went to get cement removal tools, the surgeon had somehow gotten the stem removed.Some, but not all of the cement was removed using the cement removal tools, and surgeon decided to cement in implant a size 2 accolade c stem into the remaining, originally injected and set cement.Once implanted, stem was sitting approximately 1cm proud.The stem was removed, the patient then developed an unspecified cardiac issue (rep left the o.R.To allow hospital staff to address the issue).The patient was closed without a stem being implanted.At some point after this (either the same day or the next day), the patient died.From the start of the nozzle issue to the cardiac issue, approximately 60 minutes had elapsed.Rep confirmed that no further information will be released by the hospital or surgeon.*update* on 5/25/2023 additional detail surrounding the event was obtained.The cement was mixed for approximately 1.5 minutes.The procedure began, and during initial cement injection the nozzle of the acm came off.The surgeon worked to get the nozzle re-attached which took 1-2 minutes.The surgeon was still able to inject the remaining viable cement in the acm and continued with the procedure.When placing the size 5 stem the device was sitting 2cm proud.The surgeon removed the implant and used a curette to retrieve cement from the canal but could not retrieve all cement that had been injected.Then the size 2 implant was placed which was 1cm proud.The size 2 stem was removed.The patient then developed the unspecified cardiac issue reported.
 
Manufacturer Narrative
Update included in executive summary.Reported event: an event regarding bcis involving an unknown simplex cement mix was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device identifying information (catalog number and lot code), return of the device, photographs/video of the event as it occurred, and additional details regarding storage and handling conditions are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
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Brand Name
UNKNOWN_SIMPLEX P TOBRA
Type of Device
BONE CEMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-LIMERICK
raheen business park
limerick NA
EI   NA
Manufacturer Contact
anna ryan
raheen business park
limerick NA
EI   NA
61498200
MDR Report Key16973763
MDR Text Key315661139
Report Number0002249697-2023-00570
Device Sequence Number1
Product Code LOD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_LIM
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/02/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Death;
Patient SexFemale
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