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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR; ACETLR CUP HAP 56MM W/ IMPTR
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SMITH & NEPHEW ORTHOPAEDICS LTD BHR; ACETLR CUP HAP 56MM W/ IMPTR Back to Search Results
Model Number 74120156
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 08/13/2014
Event Type  Injury  
Event Description
Revision surgery has been reported due to unknown reason.
 
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Brand Name
BHR
Type of Device
ACETLR CUP HAP 56MM 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 Key4364675
MDR Text Key5285040
Report Number3005477969-2014-00604
Device Sequence Number1
Product Code NXT
Combination Product (y/n)N
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/29/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/22/2012
Device Model Number74120156
Device Catalogue Number74120156
Device Lot Number80975 014
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 Manufactured11/23/2007
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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