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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR RESURFACING FEMORAL HEAD 42MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

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SMITH & NEPHEW ORTHOPAEDICS LTD BHR RESURFACING FEMORAL HEAD 42MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74121142
Device Problems Fracture (1260); Mechanical Problem (1384); Device Slipped (1584)
Patient Problems Injury (2348); Joint Dislocation (2374); No Code Available (3191)
Event Date 09/27/2005
Event Type  Injury  
Event Description

It was reported that left hip revision surgery was performed due to luxation of the femoral head and fracture.

 
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Brand NameBHR RESURFACING FEMORAL HEAD 42MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK CV31 3HL
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK CV31 3HL
Manufacturer Contact
sarah freestone
MDR Report Key8319449
MDR Text Key135494223
Report Number3005975929-2019-00060
Device Sequence Number1
Product Code NXT
Combination Product (Y/N)N
Reporter Country CodeBE
PMA/PMN NumberP040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,FOREIGN,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/24/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2008
Device Catalogue Number74121142
Device LOT Number27515
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/10/2003
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/08/2019 Patient Sequence Number: 1
Treatment
BHR ACETABULAR CUP, # 74120150, LOT # 27048
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