MAUDE Adverse Event Report: SMITH & NEPHEW BHR; FEMORAL HEAD

Catalog Number 74123144

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Cyst(s) (1800); Pain (1994)

Event Date 01/29/2014

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to thinning of the superior femoral neck and pain, beginning 3 months prior to revision.100-200ml of white fluid removed during surgery and large cysts noted in the pelvis.

• Brand Name: BHR
• Type of Device: FEMORAL HEAD
• Manufacturer (Section D): SMITH & NEPHEW; 1 kingmaker court; warwick technology park; warwick CV34 6WG; UK CV34 6WG
• Manufacturer (Section G): SMITH & NEPHEW; 1 kingmaker court; warwick technology park; gallows hill CV34 6WG; UK CV34 6WG
• Manufacturer Contact: michael simmonds ; 4419264823
• MDR Report Key: 3602972
• MDR Text Key: 14876880
• Report Number: 3005477969-2014-00097
• 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
• Report Date: 02/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2008
• Device Catalogue Number: 74123144
• Device Lot Number: 08GW17726
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2014
• Initial Date FDA Received: 02/03/2014
• Date Device Manufactured: 09/03/2008
• 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: ACETABULAR CUP, # 74122152, LOT # 08HW18302
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 83