MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BIRMINGHAM HIP RESURFACING; BHR ACETABULAR CUP 54MM

Catalog Number 74120154

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Toxicity (2333); Injury (2348); Ambulation Difficulties (2544); Test Result (2695)

Event Date 10/27/2015

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed.Patient had increasing difficulty with ambulation, metallosis, elevated cobalt and chromium levels as well as a pseudotumor on mri.

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.- attachment: [211978 summary.Pdf].

• Brand Name: BIRMINGHAM HIP RESURFACING
• Type of Device: BHR ACETABULAR CUP 54MM
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 7955691
• MDR Text Key: 123398590
• Report Number: 3005975929-2018-00373
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502582
• UDI-Public: 03596010502582
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Catalogue Number: 74120154
• Device Lot Number: 076299
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, # 71341013, LOT # 06BM13631; HEMI HEAD, # 74122546, LOT # 08HW18407; MODULAR SLEEVE, # 74222100, LOT # 08EW16957; FEMORAL STEM, # 71341013, LOT # 06BM13631; HEMI HEAD, # 74122546, LOT # 08HW18407; MODULAR SLEEVE, # 74222100, LOT # 08EW16957
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR