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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 4 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 4 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 71421374
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Injury (2348)
Date of Event 11/21/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to unstable hinge mechanism.The femoral component was explanted.
 
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Brand Name
LGN HK FEM ASSEMBLY SZ 4 LT
Common Device Name
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9495114
Report Number1020279-2019-04508
Device Sequence Number1542431
Product Code KRO
UDI-Device Identifier00885556414903
UDI-Public00885556414903
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 02/01/2021
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 Number71421374
Device Catalogue Number71421374
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Returned to Manufacturer12/03/2019
Initial Date Received by Manufacturer 11/22/2019
Supplement Date Received by Manufacturer01/07/2021
Initial Report FDA Received Date12/19/2019
Supplement Report FDA Received Date02/01/2021
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
71421303 LEGION HK TIBIAL BASE; 71423342 LEGION HK ISRT
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age63 YR
Patient Weight78
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