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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION NARROW PS OXIN SZ 5N LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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SMITH & NEPHEW, INC. LEGION NARROW PS OXIN SZ 5N LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL Back to Search Results
Model Number 71421265
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 01/01/1901
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that, after tkr surgery had been performed on (b)(6) 2015, the patient experienced an unspecified adverse event.This adverse event was solved by a revision surgery.Current health status of patient it is unknown.
 
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Brand Name
LEGION NARROW PS OXIN SZ 5N LT
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key12388270
Report Number1020279-2021-06596
Device Sequence Number11665128
Product Code JWH
UDI-Device Identifier00885556234006
UDI-Public00885556234006
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K112941
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/25/2021
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? Yes
Operator of Device Health Professional
Device Expiration Date08/09/2025
Device Model Number71421265
Device Catalogue Number71421265
Device Lot Number15HM07930
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 08/12/2021
Supplement Date Received by Manufacturer10/22/2021
Initial Report FDA Received Date08/30/2021
Supplement Report FDA Received Date10/25/2021
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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