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

Model Number 74121154

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Toxicity (2333)

Event Date 07/29/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on (b)(6) 2020.The patient revision was performed due to metal ion concentration.

Manufacturer Narrative

A bhr head (b)(6) and bhr cup (b)(6) were received for investigation following hip revision surgery.All of the devices involved were used in treatment, as of today, additional information has been requested for this complaint but has not become available.A review of the complaint history for the bhr cup and femoral head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the head and cup.The production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.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.Visual inspection was carried out on the returned devices.A wear patch was observed on the surface of the head, along with damage to the skirt and crack of the head.Fine scratches were observed on the bearing surface of the bhr cup, damage was observed at the multiple sites around the outer rim of the cup also on the bearing surface.Wear analysis was performed to review linear wear on the bearing surface of the head and cup.The wear images identified a wear patch on the bearing surface for the head, and a wear patch on the cup.Maximum linear wear for the head was 11.8m.On the cup maximum linear wear was 8.6m.For a combined head & cup maximum linear wear of 20.4m.Based on historic wear data, after 15.9 years in vivo, the measured combined linear wear is in line with the expected wear for a non-edge loaded smith and nephew large diameter metal-on-metal device.The position of wear on the acetabular cup shows that the head was articulating within the bearing surface to the cup.It was reported that a revision surgery was performed due to metal ion levels.Ion levels (b)(6) 2020 chrome 1.3 g/l and cobalt 0.9 g/l.No medical records or x-rays available.The product evaluation noted the measured combined linear wear is in line with the expected wear and the position of wear on the acetabular cup shows that the femoral head was articulating within the bearing surface of the cup.However, without supporting medical documentation, a thorough medical assessment cannot be performed.In the event additional medical/clinical records are received, the clinical task may be re-opened and a thorough assessment will be rendered at that time.Based on the returned parts and the information provided the probable root cause cannot be confirmed.If additional information, such as x-rays showing the historical positioning of the devices, becomes available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.Product will be stored at s+n leamington spa and is available for return upon request.

• 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 warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 10841607
• MDR Text Key: 216309062
• Report Number: 3005975929-2020-00438
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74121154
• Device Catalogue Number: 74121154
• Device Lot Number: 34975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR