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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR; ACETABULAR CUP

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SMITH & NEPHEW ORTHOPAEDICS LTD BHR; ACETABULAR CUP Back to Search Results
Device Problem Metal Shedding Debris (1804)
Patient Problems Edema (1820); Pain (1994); Weakness (2145); Toxicity (2333); Test Result (2695)
Event Date 02/18/2014
Event Type  Injury  
Event Description
It was reported that revision surgery was performed.Pain, weakness of the legs and hips, elevated cobalt and chromium levels, and fluid accumulations were reported.
 
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Brand Name
BHR
Type of Device
ACETABULAR CUP
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house spa park
harrison way
leamingon spa CV31 3HL
UK  CV31 3HL
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house spa park
harrison way
leamington spa CV31 3HL
UK   CV31 3HL
Manufacturer Contact
jennifer ferguson
4419264823
MDR Report Key3983083
MDR Text Key18574351
Report Number3005477969-2014-00447
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 Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 08/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/05/2014
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
HEMI HEAD, PART AND LOT NUMBERS UNKNOWN
Patient Outcome(s) Hospitalization; Required Intervention;
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