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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 3-4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
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SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 3-4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED Back to Search Results
Catalog Number 71453111
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported the patient has undergone multiple manipulations under anesthesia due to pain.
 
Additional Manufacturer Narrative
Following receipt of additional information concerning this case it has been determined that the initial report was submitted in error.It was discovered that the patient has not undergone any medical or surgical interventions and there have been no reports of scheduled or required interventions.Please therefore disregard this report.(b)(4).
 
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Brand Name
LGN CR HIGH FLEX XLPE SZ 3-4 9MM
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6997824
Report Number1020279-2017-00969
Device Sequence Number1183909
Product Code JWH
UDI-Device Identifier00885556033975
UDI-Public00885556033975
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K071071
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Patient
Type of Report Initial,Followup
Report Date (Section B) 11/07/2017
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 Date09/20/2021
Device Catalogue Number71453111
Device Lot Number11JM12493
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/26/2017
Supplement Date Received by Manufacturer10/26/2017
Initial Report FDA Received Date11/02/2017
Supplement Report FDA Received Date11/07/2017
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 Required Intervention;
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