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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP HAP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP HAP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74120152
Device Problem No Fail-Safe Mechanism (2990)
Patient Problem No Code Available (3191)
Event Date 06/15/2015
Event Type  Injury  
Event Description
Revision surgery due to sudo tumors.Original surgery was done on (b)(6) 2008.
 
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Brand Name
BHR ACETABULAR CUP HAP
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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
st petersburg, FL 33716
0628320660
MDR Report Key4870693
MDR Text Key6047502
Report Number3005477969-2015-00181
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 Health Professional,Company Representative,company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/30/2012
Device Catalogue Number74120152
Device Lot Number079247
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/15/2015
Date Device Manufactured10/03/2007
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;
Patient Age60 YR
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