MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121146

Device Problems Compatibility Problem (2960); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Test Result (2695); Metal Related Pathology (4530)

Event Date 10/21/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision surgery of the bhr hip implant.Primary surgery was performed over 7 years ago, the information about the hospital and exact date is unknown.The reason for revision was pain and increase of the cocr levels.The patient was revised to r3 multihole and polarstem.The outcome of the patient is unknown.

Manufacturer Narrative

It was reported that hip revision surgery was performed.During the revision, the head and cup were removed.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 and cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.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.Primary surgery was performed over 7 years ago.The reason for revision was pain and increase of the cocr levels.The outcome of the patient is unknown.Smith and nephew has not received the 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.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 46MM
• 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: 10836179
• MDR Text Key: 216121342
• Report Number: 3005975929-2020-00433
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502780
• UDI-Public: 3596010502780
• 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: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 74121146
• Device Lot Number: 73243
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2020
• 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