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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR; ACETABULAR CUP
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SMITH & NEPHEW ORTHOPAEDICS LTD BHR; ACETABULAR CUP Back to Search Results
Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
Patient Problem Test Result (2695)
Event Date 07/24/2012
Event Type  Injury  
Event Description
It was reported that revision surgery was performed due to a failed hip implant.Elevated cobalt, chromium, and titanium levels reported.Implantation in 2008.
 
Manufacturer Narrative
Exact dates of implantation and explantation added.
 
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Brand Name
BHR
Type of Device
ACETABULAR CUP
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house spa park
harrison way
leamingon spa CV31 3HL
UK  CV31 3HL
Manufacturer (Section G)
SMITH & NEPHEW
aurora house
spa park
leamington spa CV31 3HL
UK   CV31 3HL
Manufacturer Contact
michael simmonds
4419264823
MDR Report Key4031401
MDR Text Key4841661
Report Number3005477969-2014-00474
Device Sequence Number1
Product Code NXT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/21/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
FEMORAL STEM, PART AND LOT NUMBERS UNKNOWN; MODULAR SLEEVE, PART AND LOT NUMBERS UNKNOWN; HEMI HEAD, PART AND LOT NUMBERS UNKNOWN
Patient Outcome(s) Hospitalization; Required Intervention;
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