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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STANDARD OFFSET; HIGH OFFSET NEUTRAL MODULAR NECK
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SMITH & NEPHEW, INC. STANDARD OFFSET; HIGH OFFSET NEUTRAL MODULAR NECK Back to Search Results
Catalog Number 71352112
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Information (3190)
Event Date 09/10/2014
Event Type  Injury  
Event Description
Revision surgery was reported due to leg length discrepancy possibly related to back surgery patient had after initial hip surgery.
 
Manufacturer Narrative
 
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Brand Name
STANDARD OFFSET
Type of Device
HIGH OFFSET NEUTRAL MODULAR NECK
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks
memphis TN 38116
Manufacturer Contact
carla samuels
1450 brooks road
memphis, TN 38116
9013995076
MDR Report Key4111626
MDR Text Key17694032
Report Number8010764-2014-00043
Device Sequence Number1
Product Code JDH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number71352112
Device Lot Number11FTM005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received09/10/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2011
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
(B)(4)
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age62 YR
Patient Weight93
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