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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HM ST 3-4 5MM LTMD-RTLA; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY
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SMITH & NEPHEW, INC. LGN HM ST 3-4 5MM LTMD-RTLA; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY Back to Search Results
Catalog Number 71421142
Medical Device Problem Codes Detachment Of Device Component (1104); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Injury (2348)
Date of Event 12/04/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported a revision surgery of smith and nephew knee implants.
 
Additional Manufacturer Narrative
Add'l info.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached the results of our investigation.(b)(4).
 
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Brand Name
LGN HM ST 3-4 5MM LTMD-RTLA
Common Device Name
PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7089255
Report Number1020279-2017-01191
Device Sequence Number11179864
Product Code JWH
UDI-Device Identifier03596010546272
UDI-Public03596010546272
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
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,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date (Section B) 03/15/2018
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 Date02/02/2024
Device Catalogue Number71421142
Device Lot Number14BM02304
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/04/2017
Supplement Date Received by Manufacturer12/04/2017
12/04/2017
Initial Report FDA Received Date12/06/2017
Supplement Report FDA Received Date12/20/2017
03/15/2018
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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