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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 74122156
Device Problem Noise, Audible (3273)
Patient Problems Pain (1994); Swelling (2091); Discomfort (2330); Toxicity (2333)
Event Date 04/22/2014
Event Type  Injury  
Event Description
It was reported that revision surgery was performed due to increasing pain, raised metal ions, small fluid collection, clicking of hip and groin discomfort.
 
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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
aurora house
spa park
leamington spa CV34 6WG
UK   CV34 6WG
Manufacturer Contact
michael simmonds
4419264823
MDR Report Key3844947
MDR Text Key4655566
Report Number3005477969-2014-00353
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 Foreign,Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/30/2014
Device Catalogue Number74122156
Device Lot Number09FW23647 020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received05/12/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
FEMORAL HEAD, # (B)(4), LOT # 10BW25697 053
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age70 YR
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