MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS BHR ACETABULAR CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	74120158
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	12/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered from septicemia and the prosthesis had to be removed as first stage revision.
Additional Manufacturer Narrative
Initial report was submitted using incorrect manufacturing registered site code.This incident should be considered under 3005975929.As this complaint is also being handled through smith & nephew's legal teams, any responses to these queries are not immediately available to the members of smith & nephew's regulatory team and are not expected to be available for several months, if ever.This is because the timing of device return / the delivery of the information is in the control of the patient's solicitors, not smith & nephew.Smith & nephew's legal teams have confirmed that if they receive additional relevant information on this complaint (reason for complaint, including part/lot, patient, surgeon, device availability, dates of implantation or revision) they will inform us, at which point the complaint will be reopened for investigation.[(b)(4)].

• Brand Name: BHR ACETABULAR CUP 58MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS; aurora house; spa park; leamington spa TN CV31 3HL; UK CV31 3HL
• MDR Report Key: 7202415
• Report Number: 1020279-2018-00057
• Device Sequence Number: 16574535
• Product Code: NXT
• UDI-Device Identifier: 03596010195586
• UDI-Public: 03596010195586
• Combination Product (Y/N): N
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2010
• Device Catalogue Number: 74120158
• Device Lot Number: 50711 049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Initial Date Received by Manufacturer: 12/24/2017
• Supplement Date Received by Manufacturer: 12/24/2017
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 11/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention