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

Catalog Number 74120160

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Test Result (2695)

Event Date 07/31/2014

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to pain and elevated metal ions.

• 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; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: michael simmonds ; 4419264823
• MDR Report Key: 4029496
• MDR Text Key: 4881592
• Report Number: 3005477969-2014-00473
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74120160
• Device Lot Number: 7876
• Other Device ID Number: 120160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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, # 121154, LOT # 10720
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR