MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX HV WITH GENTAMICIN US 1 PACK; BONE CEMENT

Model Number 6195-1-001

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Stryker orthopaedics is a distributor of this device, which is manufactured by aap.The manufacturer has responsibility for regulatory decisions and mdr reporting.Supplier has been notified.Serious injury reports for hv products are also filed to the fda via stryker personnel.Not returned to the manufacturer.

Event Description

March 16, 2020: information received via op report indicates that the patient was implanted with competitor knee devices with simplex hv cement.The patient was later revised due to infection.It's reported that the patient underwent a total knee arthroplasty in 2014 where he was implanted with a stryker knee system.Is it further alleged that the patient underwent revision surgery on an unknown date due to infection.

• Brand Name: SIMPLEX HV WITH GENTAMICIN US 1 PACK
• 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: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9941573
• MDR Text Key: 188832238
• Report Number: 0002249697-2020-00710
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 04260056885761
• UDI-Public: 04260056885761
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2020

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 Model Number: 6195-1-001
• Device Catalogue Number: 6195-1-001
• Device Lot Number: 329BA878EU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 04/08/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 45 YR