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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 01/22/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to recurrent dislocation.Shell, liner and head explanted.Competitor devices implanted.No delay or additional injuries specified.

Manufacturer Narrative

The associated complaint devices were not made available for evaluation.Therefore a thorough product analysis could not be performed.After repeated requests, smith and nephew has been unable to obtain device details.As device details were not made available, device history record review cannot be completed.Complaint history review could not be performed with any accuracy due to lack of product information.Smith and nephew has an outstanding request with the reporter for information.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.Our clinical analysis noted the x-rays provided demonstrate the well-fixed cup that was anteverted.The root cause for the reported recurrent dislocations cannot be confirmed but are likely related to the orientation of the cup.What has caused the dislocations now cannot be concluded.However, the patient¿s body habitus, length of time in-situ, fall/trauma and bone quality as possible contributing factors cannot be ruled out.The impact to the patient beyond the revision cannot be determined at this time.Should additional information become available this issue can be re-elevated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.

• 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: 8329976
• MDR Text Key: 135847418
• Report Number: 1020279-2019-00540
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention