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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 74120154
Device Problem Insufficient Information (3190)
Patient Problems Host-Tissue Reaction (1297); Synovitis (2094); Complaint, Ill-Defined (2331); Toxicity (2333)
Event Date 01/21/2015
Event Type  Injury  
Event Description
It was reported that revision surgery was performed due to elevated metal ion levels, soft tissue reaction and effusion and synovitis.
 
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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
terry mcmahon
970 lake carillon drive
st petersburg, FL 33716
4419264823
MDR Report Key4449559
MDR Text Key5385784
Report Number3005477969-2015-00027
Device Sequence Number1
Product Code NXT
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,company representati
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/30/2011
Device Catalogue Number74120154
Device Lot Number63221
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received01/21/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2006
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 Age57 YR
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