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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 Insufficient Information (3190)
Patient Problems Muscle Weakness (1967); Pain (1994); Toxicity (2333)
Event Date 08/14/2013
Event Type  Injury  
Event Description
It was reported that revision surgery was performed due to osteolysis.Pain, weakness of the legs and hips, elevated cobalt and chromium levels and fluid accumulations around the hip reported.
 
Manufacturer Narrative
These combination of devices constitutes an off label application in the united states.
 
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Brand Name
BHR
Type of Device
ACETABULAR CUP
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
1 kingmaker court
warwick technology park
warwick CV34 6WG
UK  CV34 6WG
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS LTD
1 kingmaker court
warwick technology park
warwick CV34 6WG
UK   CV34 6WG
Manufacturer Contact
michael simmonds
4419264823
MDR Report Key3610000
MDR Text Key4067736
Report Number3005477969-2014-00150
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 02/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2014
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 Received01/30/2014
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 # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN; FEMORAL STEM, PART AND LOT # UNKNOWN
Patient Outcome(s) Hospitalization; Required Intervention;
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