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

Model Number 74120158

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Test Result (2695)

Event Date 10/14/2019

Event Type  Injury  

Event Description

Patient's surgeon is recommending a revision of the left hip due to elevated levels of cobalt and chromium in the blood.

• Brand Name: BHR ACETABULAR CUP 58MM
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping
• MDR Report Key: 10710882
• MDR Text Key: 212269782
• Report Number: 3005975929-2020-00392
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502605
• UDI-Public: 03596010502605
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 04/30/2010
• Device Model Number: 74120158
• Device Catalogue Number: 74120158
• Device Lot Number: 51541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2005
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DISTAL CENTRALISER, # 71313105, LOT # 00710226; FEMORAL STEM, # 71312113, LOT # 05DT88536; MODULAR HEAD, # 74121450, LOT # 50919; DISTAL CENTRALISER, # 71313105, LOT # 00710226; FEMORAL STEM, # 71312113, LOT # 05DT88536; MODULAR HEAD, # 74121450, LOT # 50919
• Patient Sex: Male