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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SURGICAL SIMPLEX CEMENT; BONE CEMENT
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STRYKER ORTHOPAEDICS-MAHWAH SURGICAL SIMPLEX CEMENT; BONE CEMENT Back to Search Results
Catalog Number 61910001
Device Problem Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 11/06/2019
Event Type  Death  
Manufacturer Narrative
Although 2 doses of cement were reported, it appears that the second dose was being prepared and not yet used on the patient when the reported event occurred.It is also unknown which dose of cement was used on this patient.Therefore, one dose of cement is reported with an unknown lot code and the two possible lot code references are as follows: jaa004, jba010.Device not returned.
 
Event Description
During the operation, a cement gun was used to insert a cement.Normally, the cement overflowing proximally did not overflow at all.It was doubted a possibility that the cement plug is missing.Therefore the cement remaining in the medullary cavity was scraped to remove.A trial of a stem trial was put in, but it was said that the back cement was obstructing, so a reamer was inserted to secure a space for the stem.As it was preparing to the second cement, the patient's blood pressure dropped sharply, repositioned from the recumbent position to the supine position, and performed a heart massage and waited for recovery.As it became difficult to continue the operation, the stem was not inserted, and the patient closed and exited.After that the patient was death.
 
Event Description
During the operation, a cement gun was used to insert a cement.Normally, the cement overflowing proximally did not overflow at all.It was doubted a possibility that the cement plug is missing.Therefore the cement remaining in the medullary cavity was scraped to remove.A trial of a stem trial was put in, but it was said that the back cement was obstructing, so a reamer was inserted to secure a space for the stem.As it was preparing to the second cement, the patient's blood pressure dropped sharply, repositioned from the recumbent position to the supine position, and performed a heart massage and waited for recovery.As it became difficult to continue the operation, the stem was not inserted, and the patient closed and exited.After that the patient was death.
 
Manufacturer Narrative
An event regarding the patient death involving simplex cement mix was reported.The event was not confirmed.Method & results: -device evaluation and results: functional testing was performed on three of the retain samples of the reported lot to verify the doughing time, working time and setting time of the product.The attached laboratory report show that the samples met the required specification for the test.-clinician review: no medical records were received for review with a clinical consultant.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: there is no allegation against stryker devices and products.During the operation, the patient's blood pressure dropped sharply, she repositioned from the recumbent position to the supine position.Heart massage performed and waited for recovery.The patient closed and exited.The patient passed away.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information become available to indicate further evaluation is warranted, this record will be re-opened.
 
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Brand Name
SURGICAL SIMPLEX CEMENT
Type of Device
BONE CEMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key9412902
MDR Text Key170027145
Report Number0002249697-2019-03951
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 04/17/2020
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? No
Device Operator Health Professional
Device Expiration Date01/31/2024
Device Catalogue Number61910001
Device Lot NumberJAA004
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/06/2019
Initial Date FDA Received12/04/2019
Supplement Dates Manufacturer Received03/21/2020
Supplement Dates FDA Received04/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age97 YR
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