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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 5-6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
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SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 5-6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED Back to Search Results
Catalog Number 71453121
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 05/17/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported a right knee revision surgery was performed due to acute septic knee.The insert was removed, knee washed out and a new insert implanted.
 
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.
 
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Brand Name
LGN CR HIGH FLEX XLPE SZ 5-6 9MM
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6644103
Report Number1020279-2017-00430
Device Sequence Number13723853
Product Code JWH
UDI-Device Identifier00885556033982
UDI-Public00885556033982
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K071071
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/29/2017
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 Health Professional
Device Expiration Date03/07/2026
Device Catalogue Number71453121
Device Lot Number16CM06592
Initial Date Received by Manufacturer 05/17/2017
Supplement Date Received by Manufacturer05/17/2017
Initial Report FDA Received Date06/15/2017
Supplement Report FDA Received Date09/29/2017
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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