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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIGH OFFSET NEUTRAL MODULAR NECK; PRSTHSS,HIP,SEMICNSTRAIND,MTL/PLYMR,POROUSUNCMNTD
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SMITH & NEPHEW, INC. HIGH OFFSET NEUTRAL MODULAR NECK; PRSTHSS,HIP,SEMICNSTRAIND,MTL/PLYMR,POROUSUNCMNTD Back to Search Results
Catalog Number 71352112
Medical Device Problem Code Corroded (1131)
Health Effect - Clinical Codes Pain (1994); Injury (2348)
Date of Event 12/18/2015
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to corrosion between femoral stem and modular neck.
 
Additional Manufacturer Narrative
Please review attached for investigation results.(b)(4).
 
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Brand Name
HIGH OFFSET NEUTRAL MODULAR NECK
Common Device Name
PRSTHSS,HIP,SEMICNSTRAIND,MTL/PLYMR,POROUSUNCMNTD
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6883089
Report Number1020279-2017-00779
Device Sequence Number11058580
Product Code LPH
UDI-Device Identifier03596010619549
UDI-Public03596010619549
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K072417
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2015
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date (Section B) 01/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date04/10/2021
Device Catalogue Number71352112
Device Lot Number11BTM0011B
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/19/2017
Supplement Date Received by Manufacturer09/19/2017
Initial Report FDA Received Date09/21/2017
Supplement Report FDA Received Date01/02/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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