*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-12-19 for * manufactured by Smith And Nephew, Inc..

Event Text Entries

[754517] Patient had an open reduction internal fixation with richards hip screw. At follow-up visit 2 weeks later, increased pain. X-rays revealed lag screw had cut through the femoral head. Returned to surgery one month from original surgery for revision of intertrochanteric hip fracture to cemented revision femoral stem with bipolar head with removal of richards hip screw and side plate.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 976174
• MDR Report Key: 976174
• Date Received: 2007-12-19
• Date of Report: 2007-12-19
• Date of Event: 2007-09-19
• Report Date: 2007-12-19
• Date Reported to FDA: 2007-12-19
• Date Added to Maude: 2008-01-10
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• 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: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: *
• Generic Name: HARDWARE, ORTHOPEDIC, HIP PLATE
• Product Code: NDF
• Date Received: 2007-12-19
• Model Number: *
• Catalog Number: *
• Lot Number: 05BT87224
• ID Number: *
• Device Availability: N
• Device Age: 1 DY
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 944142
• Manufacturer: SMITH AND NEPHEW, INC.
• Manufacturer Address: ORTHOPAEDIC DIVISION 1450 EAST BROOKS ROAD MEMPHIS TN 38116 US

Device Sequence Number: 2

• Brand Name: *
• Generic Name: HARDWARE, ORTHOPEDIC, HIP SCREW LAG
• Product Code: NDJ
• Date Received: 2007-12-19
• Model Number: *
• Catalog Number: *
• Lot Number: 04KT8422
• ID Number: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 944143
• Manufacturer: SMITH AND NEPHEW, INC.
• Manufacturer Address: ORTHOPAEDIC DIVISION 1450 EAST BROOKS ROAD MEMPHIS TN 38116 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2007-12-19