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U.S. Department of Health and Human Services

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

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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 Back to Search Results
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).
 
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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 Key17525474
MDR Text Key321159884
Report NumberMW5132415
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Number of Events Reported1
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 Number1) 7482-0409; 7382-6032; 7382-
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2023
Patient Sequence Number1
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