• 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 SIMPLEX P - CE ABC FD 10-PK BONE CEMENT, ANTIBIOTIC

  • 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 SIMPLEX P - CE ABC FD 10-PK BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number 61969010
Device Problem Insufficient Information (3190)
Patient Problems Pulmonary Embolism (1498); Cardiac Arrest (1762); Death (1802); Bone Fracture(s) (1870); Injury (2348)
Event Date 08/04/2019
Event Type  Death  
Manufacturer Narrative

Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other 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.

 
Event Description

The pharmacist at the hospital reported the following event : "an old patient has been implanted a hip prosthesis following a fracture of the femur. The surgeon who performed the intervention used a bone cement in order to fix the rod. At this very moment, the patient had a cardiac arrest following a pulmonary embolism (rare but serious adverse consequence described in the ifu). The patient was resuscitated and then taken to the recovery room where he had a second cardiac arrest and died the same day.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSIMPLEX P - CE ABC FD 10-PK
Type of DeviceBONE CEMENT, ANTIBIOTIC
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
joanne mahony
ida industrial estate
carrigtwohill NA
214532800
MDR Report Key8878696
MDR Text Key153818329
Report Number0002249697-2019-02778
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 08/09/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/09/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2020
Device Catalogue Number61969010
Device LOT NumberBDA009
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/09/2019 Patient Sequence Number: 1
-
-