MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR; ACETABULAR CUP

Catalog Number 74120152

Device Problems Device Slipped (1584); Noise, Audible (3273)

Patient Problems Pain (1994); Toxicity (2333)

Event Type  Injury  

Event Description

It was reported that revision surgery was performed.In 2012/2013, the patient suffered pain and squeaking.His cobalt (1490 nmol/l) and chromium (758 nmol/l) levels were found to be elevated.In (b)(6) 2013, he was advised that radiographs were showing some femoral neck resorption and early loosening of the acetabular implant.The patient underwent revision surgery in (b)(6) 2014.

• Brand Name: BHR
• Type of Device: ACETABULAR CUP
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: michael simmonds ; 4419264823
• MDR Report Key: 4187441
• MDR Text Key: 21237745
• Report Number: 3005477969-2014-00538
• Device Sequence Number: 1
• Product Code: NXT
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2012
• Device Catalogue Number: 74120152
• Device Lot Number: 07EW11827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2014
• Date Device Manufactured: 07/26/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, # 74123144, LOT # 07JW13442
• Patient Outcome(s): Hospitalization; Required Intervention