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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 Insufficient Information (3190)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 11/20/2018
Event Type  Death  
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.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.Not returned to the manufacturer.
 
Event Description
Since bha was operated by another company's stem and it became the use by a cement stem.Attempted to insert our simplex cement, but it resulted in death due to the patient's cardiopulmonary arrest during filling.
 
Event Description
Since bha was operated by another company's stem and it became the use by a cement stem.Attempted to insert our simplex cement, but it resulted in death due to the patient's cardiopulmonary arrest during filling.
 
Manufacturer Narrative
Patient's weight was corrected from 52 to 52kgs.
 
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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 Key8490788
MDR Text Key141164918
Report Number0002249697-2019-01559
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 04/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2022
Device Catalogue Number61910002
Device Lot NumberJCZ022
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/21/2018
Initial Date FDA Received04/08/2019
Supplement Dates Manufacturer Received04/09/2019
Supplement Dates FDA Received04/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Weight52
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