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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 1-2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 1-2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL Back to Search Results
Catalog Number 71453201
Medical Device Problem Codes Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Failure of Implant (1924); Unspecified Infection (1930); Pain (1994)
Date of Event 03/23/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Customer indicated that there is no product/device to be returned for investigation analysis.
 
Event or Problem Description
It was reported a revision surgery was performed due to infection.The patient had pain.
 
Additional Manufacturer Narrative
(b)(4).
 
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Brand Name
LGN PS HIGH FLEX XLPE SZ 1-2 9MM
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 Key6485863
Report Number1020279-2017-00255
Device Sequence Number11062346
Product Code JWH
UDI-Device Identifier00885556033784
UDI-Public00885556033784
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K071071
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/02/2017
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 Physician
Device Expiration Date09/16/2025
Device Catalogue Number71453201
Device Lot Number15JT59075
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/23/2017
Supplement Date Received by Manufacturer03/23/2017
Initial Report FDA Received Date04/12/2017
Supplement Report FDA Received Date10/02/2017
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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