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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR; ACETLR CUP HAP 52MM W/ IMPTR
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SMITH & NEPHEW ORTHOPAEDICS LTD BHR; ACETLR CUP HAP 52MM W/ IMPTR Back to Search Results
Model Number 74120152
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 10/15/2014
Event Type  Injury  
Event Description
A revision surgery has been reported due to unknown reason.
 
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Brand Name
BHR
Type of Device
ACETLR CUP HAP 52MM W/ IMPTR
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
1 kingmaker court
gallows hill CV34 6WG
UK  CV34 6WG
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK   CV31 3HL
Manufacturer Contact
terry mcmahon
970 lake carillon drive
baar
st. petersburg, FL 33716
0628320660
MDR Report Key4368029
MDR Text Key5260380
Report Number3005477969-2014-00606
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,company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 12/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2008
Device Model Number74120152
Device Catalogue Number74120152
Device Lot Number30068 109
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received12/10/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/21/2003
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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