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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW BHR; ACETLR CUP HAP 52MM W/ IMPTR
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SMITH & NEPHEW BHR; ACETLR CUP HAP 52MM W/ IMPTR Back to Search Results
Catalog Number 74120152
Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
Patient Problems Host-Tissue Reaction (1297); Pain (1994); Chemical Exposure (2570); Test Result (2695)
Event Date 11/26/2013
Event Type  Injury  
Event Description
It was reported that revision surgery was performed due to pain, elevated metal ion levels and a soft tissue reaction.The patient reported that following implantation the left hip was never 100% comfortable and has always had some degree of discomfort and pain.
 
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Brand Name
BHR
Type of Device
ACETLR CUP HAP 52MM W/ IMPTR
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 CV31 3HL
UK   CV31 3HL
Manufacturer Contact
michael simmonds
MDR Report Key4316775
MDR Text Key5258250
Report Number3005477969-2014-00570
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,Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2014
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 Number07JW13609
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/04/2014
Date Device Manufactured01/22/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
FEMORAL HEAD, # 74121146, LOT # 07EW12004
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age69 YR
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