MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 40MM ID INTL COCR LINER 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71335852

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Sepsis (2067); Metal Related Pathology (4530); Solid Tumour (4552)

Event Date 08/24/2018

Event Type  Injury  

Event Description

It was reported that, after a total hip replacement was conducted on (b)(6) 2009, the patient experienced staphylococcus sepsis and presented a pseudotumor caused by armed.This adverse event was treated with a revision surgery performed on (b)(6) 2018, in which the pseudotumor was extirpated and the bhr modular head 40mm and the r3 40mm id intl cocr liner 52mm were replaced.Patient's current health status is unknown.

Manufacturer Narrative

H3, h6: it was reported that total hip revision surgery was performed.During the revision, the modular head and the r3 liner were explanted.As of today, the implanted devices, all of which were used in said revision, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the r3 liner, r3 shell, modular head, stem and modular sleeve 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 r3 shell, modular head, stem or sleeve.A similar complaint has been identified for the r3 liner.However, as the device is no longer sold, no action is to be taken.On account of the fact devices reportedly involved in this incident were not returned for evaluation, the relevant production records were reviewed.All released devices involved met manufacturing specifications at the time of production.It was also confirmed that all the devices were sterilised.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.No further actions are required at this time.The available medical documents were reviewed.The finite data provided in the crfs (may) support the complaint; however, the limited information was insufficient to base an assessment of the root cause and patient impact beyond the reported events.Should clinical documentation become available in the future, a thorough medical assessment may be rendered at that time.Without return of the applicable devices or further information we cannot advance the investigation or confirm the details supplied in this complaint.Furthermore, our investigation remains inconclusive and a definitive root cause cannot be determined.Due to the insufficient information provided, we are unable to determine specific factors known to contribute to the alleged fault.If the devices or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: R3 40MM ID INTL COCR LINER 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 12344565
• MDR Text Key: 267410106
• Report Number: 3005975929-2021-00380
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010596109
• UDI-Public: 3596010596109
• Combination Product (y/n): N
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 71335852
• Device Lot Number: 08FW17427
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 93