MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 42MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121142

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Information (3190); Insufficient Information (4580)

Event Date 09/30/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision surgery of a bhr construct because of an unspecified reason.As the cup seemed well-fixed, the cup was retained and the femoral head was explanted.The patient was then converted to thr with a custom-made polyethylene insert, a metal femoral head and a stem.The information about the surgeon, hospital and date of primary implantation is unknown.The patient outcome is unknown.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the head was removed.The cup remained implanted.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.Without definitive part and lot numbers a complaint history, dhr review, device labelling and risk management cannot be performed for the devices involved.Should the lot / batch / serial number become available at a later date then the complaint history, dhr review, device labelling and risk management task will be re-opened and completed.Smith and nephew has not received device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the head was removed.The cup remained implanted.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.Without definitive lot numbers a complete complaint history review cannot be performed for the devices involved.A review of the complaint history review was performed using the part number for a 42mm bhr head in search of complaints throughout the lifetime of the product.Other complaints have been identified for the 42mm bhr head.As no device lot numbers were provided for investigation, a manufacturing record review and device labelling / ifu review could not be performed.Without the medical details of the reported issue, failure modes and reason for revision involved in this complaint, a risk management review cannot be performed.If more information is received, this investigation will be reopened.Smith and nephew has not received device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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 42MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa warwickshire ; UK
• MDR Report Key: 10816193
• MDR Text Key: 215495895
• Report Number: 3005975929-2020-00430
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502773
• UDI-Public: 3596010502773
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74121142
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 01/21/2021; 03/19/2021
• Supplement Dates FDA Received: 01/26/2021; 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RESURFACING FEMORAL HEAD 50MM (74121150); RESURFACING FEMORAL HEAD 50MM (74121150)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR