MAUDE Adverse Event Report: SMITH AND NEPHEW 1) 9 HOLE PROXIMAL FEMUR PLATE X 1; 4.5MM X 32MM NON-LOCKING SCREW X 1; 4.5MM X; PLATE, FIXATION, BONE

Catalog Number 1) 7482-0409; 7382-6032; 7382-

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Patient initially treated with another manufacturers hardware on (b)(6) 2014.Patient developed infection and returned to the operating room on (b)(6) 2014 for hardware removal.Patient was implanted with smith and nephew plates and screws on (b)(6) 2014.Patient had persistent infection and underwent three (3) revision surgeries on the following dates with smith and nephew hardware.Hardware implanted on (b)(6) 2014 was removed and patient was revised to another plate and screw construct on (b)(6) 2014.Revision surgery was performed on (b)(6) 2015 to remove hardware implanted on (b)(6) 2014.Another revision surgery was performed on (b)(6) 2016 to remove the hardware implanted on (b)(6) 2015.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: 1) 9 HOLE PROXIMAL FEMUR PLATE X 1; 4.5MM X 32MM NON-LOCKING SCREW X 1; 4.5MM X
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH AND NEPHEW
• MDR Report Key: 17525474
• MDR Text Key: 321159884
• Report Number: MW5132415
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: 1) 7482-0409; 7382-6032; 7382-
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1