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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW BHR; ACETABULAR CUP
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SMITH & NEPHEW BHR; ACETABULAR CUP Back to Search Results
Catalog Number 74120152
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 11/19/2014
Event Type  Injury  
Manufacturer Narrative
Resubmitted initial report following failure (b)(6) 2015 due to date format error.Final report issued (b)(6) 2015.
 
Event Description
Revision surgery was performed.
 
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Brand Name
BHR
Type of Device
ACETABULAR CUP
Manufacturer (Section D)
SMITH & NEPHEW
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
claudia odoy
schachenallee 29
aarau 5001
SZ   5001
4419264823
MDR Report Key5253870
MDR Text Key33595988
Report Number3005477969-2015-00110
Device Sequence Number1
Product Code NXT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/26/2009
Device Catalogue Number74120152
Device Lot Number35000 111
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/01/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received04/02/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/27/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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