MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP IMPLANT; PRSTHSS, HP, HM-, TRNNN-BRNG, FMORL, MTL/PLYCTL

Catalog Number 71354234

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 08/04/2017

Event Type  Injury  

Event Description

Study id: (b)(4).Subject id: (b)(6).Ae#: 2.A revision surgery was performed due to a dislocation on left hip.

Manufacturer Narrative

The device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.The device was manufactured in 2015.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Our clinical/medical team noted: without the relevant clinical information a thorough medical investigation cannot be rendered.Should any additional clinical information be provided this complaint will be re-assessed.A review of the risk management file and instructions of use for the product was completed.Factors and/or some potential probable causes that could include but not limited to improper labeling, improper or failure to follow ifu, and surgical technique.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: HIP IMPLANT
• Type of Device: PRSTHSS, HP, HM-, TRNNN-BRNG, FMORL, MTL/PLYCTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9580027
• MDR Text Key: 183942567
• Report Number: 1020279-2020-00204
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: K150790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71354234
• Device Lot Number: 15MM12810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 45