MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX TOBRAMYCIN 1 PK; BONE CEMENT

Catalog Number 61971001

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Arrest (1762)

Event Date 04/03/2020

Event Type  Injury  

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.

Event Description

Blood pressure drops when using cement.The stem was inserted before the cement hardened, but the patient's condition deteriorated before complete hardening, so the patient shifted from the lateral position to the supine position and started cardiac massage.He recovered from cardiopulmonary arrest, but moved to the icu because his condition was not stable.The surgical site is closed with a simple suture.The doctor's opinion has not been confirmed because the attending physician (surgeon) moved to the icu to accompany the patient.The causal relationship with cement is unknown at this stage.After the interview with dr., if there is any necessary investigation, it will be requested.

• Brand Name: SIMPLEX TOBRAMYCIN 1 PK
• 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 ; IE NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10016987
• MDR Text Key: 189581783
• Report Number: 0002249697-2020-00844
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: JP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2020

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 Catalogue Number: 61971001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2020
• Initial Date FDA Received: 05/01/2020
• 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 Number: 1
• Patient Outcome(s): Other