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 01/01/1901

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to dislocation.The cup was exchanged.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that, based on the literature review, dislocation after surgery has been attributed to several different causes, including implant position, soft-tissue tension or instability, disruption of the trochanteric abductor mechanism, impingement, lack of patient cooperation, and unknown factors.The principal goal of the study was to determine the prevalence¿s of dislocation after surgery with two different surgical techniques.The results of the retrospective study confirmed that with use of the new technique, the prevalence of dislocation decreased from 2.8% to 0.6%.During the studying it was reported that a revision surgery was performed due to dislocation, the cup was exchanged.After three requests, no individual clinical information has been provided for inclusion in this medical investigation.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on the medical investigation, some potential probable causes of this event could include device positioning or lack of patient cooperation.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.

• 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: 9491647
• MDR Text Key: 171892562
• Report Number: 1020279-2019-04492
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 03/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention