MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 02/22/2019

Event Type  Death  

Event Description

A new legal claim was reported due to a death that is believed to be a direct result of the faulty design of smith & nephew hip replacement devices.The cause of death is unknown, as are the devices involved, which part numbers have not been provided.

Manufacturer Narrative

This case reported a death of a patient who underwent a hip replacement using smith and nephew devices.After repeated requests, smith and nephew has been unable to obtain information pertaining to the devices associated with the event.Smith and nephew has an outstanding request with the reporter for information.As device details were not made available, device history record review cannot be completed.Complaint history review could not be performed due to the lack of product information.The cause of death is unknown.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.Without the return of the actual product involved and no product information available, our investigation of this report is inconclusive.Our clinical evaluation could not performed at this time as no clinical supporting documentation was provided.Should clinical documentation becomes available in the future, the clinical medical task may be re-evaluated.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, this complaint will be reopened and reevaluated.

• Brand Name: HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8434598
• MDR Text Key: 139285042
• Report Number: 1020279-2019-01111
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death