BHR 900250

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-04-24 for BHR 900250 manufactured by Smith & Nephew, Inc., Orthopaedic Div.

Event Text Entries

[608461] It was reported due to a femoral neck fracture of the bone, revision surgery was performed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1020279-2007-00090
• MDR Report Key: 841757
• Report Source: 05
• Date Received: 2007-04-24
• Date of Report: 2007-04-24
• Date Mfgr Received: 2007-04-24
• Date Added to Maude: 2007-04-30
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: MRS MELANIE TRAVIS, REG COMPLIANCE
• Manufacturer Street: 1450 BROOKS ROAD
• Manufacturer City: MEMPHIS TN 38116
• Manufacturer Country: US
• Manufacturer Postal: 38116
• Manufacturer Phone: 9013996233
• Manufacturer G1: SMIHT & NEPHEW INC.
• Manufacturer Street: 1450 BROOKS ROAD
• Manufacturer City: MEMPHIS TN 38116
• Manufacturer Country: US
• Manufacturer Postal Code: 38116
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BHR
• Generic Name: CUP
• Product Code: JDD
• Date Received: 2007-04-24
• Model Number: NA
• Catalog Number: 900250
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: Y
• Date Removed: U
• Device Sequence No: 1
• Device Event Key: 828987
• Manufacturer: SMITH & NEPHEW, INC., ORTHOPAEDIC DIV
• Manufacturer Address: 1450 BROOKS ROAD MEMPHIS TN 38116 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2007-04-24