• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP Back to Search Results
Catalog Number 74122154
Event Date 01/31/2012
Event Type  Injury  
Event Description

It was reported that revision surgery was performed due to pain and an adverse reaction to metal debris.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBHR
Type of DeviceACETABULAR CUP
Manufacturer (Section F)
SMITH & NEPHEW ORTHOPAEDICS LTD
1 kingmaker court
gallows hill
UNITED KINGDOM CV34 6WG
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
1 kingmaker court
gallows hill
UNITED KINGDOM CV34 6WG
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS LTD
1 kingmaker court
warwick technology park
warwick
UNITED KINGDOM CV34 6WG
Manufacturer Contact
michael simmonds
0 441 926482341
Device Event Key2537984
MDR Report Key2512518
Event Key2409251
Report Number3005477969-2012-00118
Device Sequence Number1
Product CodeNXT
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/02/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date05/31/2014
Device Catalogue Number74122154
Device LOT Number09EW23344 022
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/05/2012
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received01/31/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/02/2012 Patient Sequence Number: 1
Treatment
FEMORAL HEAD PART# 74123148, LOT# UNKNOWN)
FEMORAL HEAD, # 74122154, LOT# -2347 029 (PARTIAL)
-
-