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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN REV TIBIA BASE SZ 5 LT; JWH   PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
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SMITH & NEPHEW, INC. LGN REV TIBIA BASE SZ 5 LT; JWH   PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY Back to Search Results
Model Number 71424005
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 01/08/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to infection.Antibiotic spacers were also implanted.
 
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Brand Name
LGN REV TIBIA BASE SZ 5 LT
Common Device Name
JWH   PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9641674
Report Number1020279-2020-00410
Device Sequence Number11374924
Product Code JWH
UDI-Device Identifier03596010546098
UDI-Public03596010546098
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K043440
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 12/22/2020
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 Model Number71424005
Device Catalogue Number71424005
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/17/2020
Supplement Date Received by Manufacturer11/30/2020
Initial Report FDA Received Date01/29/2020
Supplement Report FDA Received Date12/22/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
71420538, GNS II CON INSERT.; 71424029, LGN PRESSFIT STEM.; 71424031, LGN PRESSFIT STEM.; 71424223, LGN OFFSET COUPLER 2.; 71424225, LGN OFFSET COUPLER.; UNKNOWN FEMORAL COMPONENT.; UNKNOWN PATELLA.
Patient Age73 YR
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