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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION TIB BASE W/JOURNEY LOCK SZ 3 L; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
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SMITH & NEPHEW, INC. LEGION TIB BASE W/JOURNEY LOCK SZ 3 L; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED Back to Search Results
Catalog Number 71933569
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Date of Event 09/15/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision was performed on the left knee to revise the poly and tibia.
 
Additional Manufacturer Narrative
Please review attached for the investigation results.(b)(4).
 
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Brand Name
LEGION TIB BASE W/JOURNEY LOCK SZ 3 L
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6921950
Report Number1020279-2017-00831
Device Sequence Number819410
Product Code JWH
UDI-Device Identifier00885556061794
UDI-Public00885556061794
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
K043440
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 12/13/2017
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 No Information
Device Catalogue Number71933569
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/15/2017
Supplement Date Received by Manufacturer09/15/2017
Initial Report FDA Received Date10/06/2017
Supplement Report FDA Received Date12/13/2017
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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