MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 09/30/2019

Event Type  Death  

Event Description

It was reported that the patient passed away in 2015 after receiving two hip implants that were apparently defective.There is no confirmation that the death was caused by the smith and nephew products.

Event Description

It was reported that the patient developed an abscess in his right hip flexor approximately a month after his surgery which required hospitalization for 6 days.This patient passed away in 2015 after receiving two hip implants that were apparently defective.There is no confirmation that the death was caused by the smith and nephew products.

Manufacturer Narrative

It was reported that the patient developed an abscess in his right hip flexor approximately a month after his surgery.This patient passed away in 2015.There is no confirmation that the death was caused by the smith and nephew products.As device details were not made available, device history record and complaint history review cannot be completed.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.A clinical analysis noted that the reported abscess was likely related to the procedure as the device functioned well.The patient had successful physical therapy and functioned and returned to adl¿s following the hospitalization and treatment for the abscess.The report of the death 2 years after the implantation.The certificate of death notes the patient¿s cause of death was respiratory failure and pleural effusion and not the fault of the smith and nephew device itself.However, the patient¿s chronic conditions as contributing factors cannot be ruled out.No further clinical/medical assessment is warranted at this time.Without the return of the actual product involved and no product information available, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9247989
• MDR Text Key: 164062347
• Report Number: 1020279-2019-03766
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2019

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
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 09/30/2019; 11/07/2019
• Supplement Dates FDA Received: 11/06/2019; 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death