MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P - CE ABC FD 10-PK; BONE CEMENT, ANTIBIOTIC

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.

• Brand Name: SIMPLEX P - CE ABC FD 10-PK
• Type of Device: BONE 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 Key: 8878696
• MDR Text Key: 153818329
• Report Number: 0002249697-2019-02778
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• 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 Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 61969010
• Device Lot Number: BDA009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention