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

Catalog Number 74120146

Device Problem Protective Measures Problem (3015)

Patient Problem No Code Available (3191)

Event Date 01/07/2019

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to metallosis.

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

• Brand Name: BHR RESURFACING ACETABULAR CUP 46MM
• 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: 8277114
• MDR Text Key: 134074567
• Report Number: 3005975929-2019-00030
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502544
• UDI-Public: 03596010502544
• 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: 05/14/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2010
• Device Catalogue Number: 74120146
• Device Lot Number: 51504
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2019
• Initial Date FDA Received: 01/25/2019
• Supplement Dates Manufacturer Received: 01/18/2019
• Supplement Dates FDA Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODULAR HEAD, # 74121538, LOT # 22009; MODULAR HEAD, # 74121538, LOT # 22009
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR