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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS NP FEM SZ 6 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
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SMITH & NEPHEW, INC. LEGION PS NP FEM SZ 6 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED Back to Search Results
Catalog Number 71423226
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); Synovitis (2094); Injury (2348)
Date of Event 10/06/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that patient underwent revision surgery due infection, which was suspected and confirmed intraoperatively with a sinovasure defensin test.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see the attached file for the results of our investigation.(b)(4).
 
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Brand Name
LEGION PS NP FEM SZ 6 LT
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6990062
Report Number1020279-2017-00944
Device Sequence Number13615322
Product Code JWH
UDI-Device Identifier03596010611413
UDI-Public03596010611413
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K060742
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date (Section B) 12/18/2017
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 Health Professional
Device Expiration Date06/13/2026
Device Catalogue Number71423226
Device Lot Number16FM19922
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/06/2017
Supplement Date Received by Manufacturer10/06/2017
10/06/2017
Initial Report FDA Received Date10/31/2017
Supplement Report FDA Received Date11/24/2017
12/18/2017
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
GNS II CMT TIB SIZE 6 {} LEFT/71420170/17CM17221; GNS II RESURF PAT 35MM/71420578/17BM19802; LGN PS HIGH FL XLPE SZ 5-6 13MM/71453223/16LT78502
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age75 YR
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