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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD; PROSTHESIS, HIP, FEMORAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD; PROSTHESIS, HIP, FEMORAL, RESURFACING Back to Search Results
Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Failure of Implant (1924); Injury (2348); No Information (3190)
Event Type  Injury  
Event Description
It was reported that revision surgery of the femoral head only was performed due breakage of the femoral neck.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Revision occurred either (b)(6) 2017.
 
Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
 
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Brand Name
RESURFACING FEMORAL HEAD
Type of Device
PROSTHESIS, HIP, FEMORAL, RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK  CV31 3HL
MDR Report Key6809789
MDR Text Key83218476
Report Number3005975929-2017-00246
Device Sequence Number1
Product Code KXA
Combination Product (y/n)N
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 05/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received08/14/2017
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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