MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121150

Device Problem Migration (4003)

Patient Problem Implant Pain (4561)

Event Date 10/16/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: case (b)(4).

Event Description

It was reported that, after a birmingham hip resurfacing system the left side was painful, 8 years after the surgery a bone scan showed possible slight migration of the resurfacing femoral head 50mm.So the left side was converted to a primary hip with a birmingham dual mobility hip and the cup was retained.Patient was doing well and the other hip (had a birmingham hip resurfacing system was doing well.

Manufacturer Narrative

H3, h6: it was reported that, after a birmingham hip resurfacing system the left side was painful, 8 years after the surgery a bone scan showed possible slight migration of the resurfacing femoral head 50mm.So the left side was converted to a primary hip with a birmingham dual mobility hip and the cup was retained.Patient was doing well and the other hip had a birmingham hip resurfacing system was doing well.As of today, the implanted device that was used in treatment has not been returned for evaluation.A review of the historical complaints data for the alleged device was performed using batch number, part number and the reported failure mode to evaluate patterns of repeated failures or defects.No other similar complaints have been identified for the head, and this failure will continue to be monitored.In the absence of the actual device, the production records were reviewed for the device reportedly involved in this incident.The released device involved met manufacturing specifications upon release for distribution.The review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the product and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.No further escalation actions are required.As of the date of this medical investigation, the requested supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported pain, possible slight migration and subsequent revision.With the limited information provided, the patient impact beyond the reported revision cannot be determined.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.A definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement.Should the device or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: RESURFACING FEMORAL HEAD 50MM
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18078583
• MDR Text Key: 327476535
• Report Number: 3005975929-2023-00157
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502797
• UDI-Public: 03596010502797
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2020
• Device Catalogue Number: 74121150
• Device Lot Number: 15KW09640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2023
• Date Device Manufactured: 10/27/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention