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

Model Number 74121142

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 08/06/2019

Event Type  Injury  

Event Description

It was reported that a left hip closed reduction was performed on (b)(6) 2019.The patient outcome is unknown.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.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.A review of the complaint history for the bhr head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.A similar complaint has been identified for the head.However, both complaints are for the same patient/device.In the absence of the actual devices, 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.The available medical documents were reviewed.Based on the information provided, the revision was performed as a result of loosening of the femoral component, due to weakening of the femoral neck bone.Additionally, it was indicated that the patient was a very large woman who had very poor acetabular bone quality and advanced dysplasia with small bony anatomy.The root cause of the dislocation that occurred on revision post-op day one cannot be concluded, as there was no additional information provided concerning the method of the dislocation.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 CV31 3HL; UK CV31 3HL
• MDR Report Key: 10311015
• MDR Text Key: 199980824
• Report Number: 3005975929-2020-00258
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502773
• UDI-Public: 03596010502773
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74121142
• Device Catalogue Number: 74121142
• Device Lot Number: 82123
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention