MAUDE Adverse Event Report: SMITH & NEPHEW, INC.; GENESISII TIBIAL INSERT AND FEMORAL COMPONENT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 09/02/2014

Event Type  Death  

Event Description

It was reported that a revision surgery was performed.The cause is unknown at this time.

Manufacturer Narrative

Manufacturer Narrative

Information was received that there was a patient death.No other information has been provided at this time.Details of the cause of death have been requested.

Manufacturer Narrative

Correction : checked box indicated for death.Patient death was previously reported, however box was not checked.

• Type of Device: GENESISII TIBIAL INSERT AND FEMORAL COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: connie mcbroom ; 1450 brooks road; memphis, TN 38116 ; 9013995985
• MDR Report Key: 4089131
• MDR Text Key: 4743940
• Report Number: 1020279-2014-00556
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2014
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention