MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74121154

Device Problems Collapse (1099); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to the collapse of the femoral head.

Manufacturer Narrative

It was reported that hip revision surgery was performed.During the revision, the bhr head was removed.No other information was provided regarding the other implanted devices.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.A review of the complaint history for the head, was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.It has been communicated via email that no additional supporting clinical information will be provided.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: RESURFACING FEMORAL HEAD 54MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3H; UK CV31 3H
• MDR Report Key: 8978666
• MDR Text Key: 157034064
• Report Number: 3005975929-2019-00316
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502803
• UDI-Public: 03596010502803
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2012
• Device Model Number: 74121154
• Device Catalogue Number: 74121154
• Device Lot Number: 74859
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 95