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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OX CONSTRAINED FEM 5 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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SMITH & NEPHEW, INC. LGN OX CONSTRAINED FEM 5 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL Back to Search Results
Model Number 71421165
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 11/30/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery had to be performed due to prosthetic infection.The legion ox constrained fem 5 lt was implanted on (b)(6) 2017 and explanted the same year on (b)(6) 2017.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand Name
LGN OX CONSTRAINED FEM 5 LT
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key10012398
Report Number1020279-2020-01400
Device Sequence Number3303515
Product Code JWH
UDI-Device Identifier03596010543844
UDI-Public03596010543844
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 Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 12/29/2020
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 Expiration Date02/06/2023
Device Model Number71421165
Device Catalogue Number71421165
Device Lot Number13BM03030
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/06/2020
Supplement Date Received by Manufacturer12/01/2020
Initial Report FDA Received Date04/29/2020
Supplement Report FDA Received Date12/29/2020
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;
Patient Age81 YR
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