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

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

It was reported that revision surgery was performed.The surgeon reportedly believes that this was due to a metal allergy and not a mechanical or alignment issue with the device.

Manufacturer Narrative

• Brand Name: BHR
• Type of Device: ACETABULAR CUP
• Manufacturer (Section D): SMITH & NEPHEW; 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: terry mcmahon ; 970 lake carillon drive; st. petersburg, FL 33716 ; 4419264823
• MDR Report Key: 4627532
• MDR Text Key: 22150923
• Report Number: 3005477969-2015-00089
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention