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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN XLPE DISHED ISRT SZ 1-2 21MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CMNTD, POLYMER/METAL
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SMITH & NEPHEW, INC. LGN XLPE DISHED ISRT SZ 1-2 21MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CMNTD, POLYMER/METAL Back to Search Results
Catalog Number 71453276
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); Injury (2348)
Date of Event 10/30/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a patient underwent a revision surgery due to infection three years later from the primary surgery.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.[(b)(4)].
 
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Brand Name
LGN XLPE DISHED ISRT SZ 1-2 21MM
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CMNTD, POLYMER/METAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7051092
Report Number1020279-2017-01085
Device Sequence Number11125319
Product Code JWH
UDI-Device Identifier00885556255711
UDI-Public00885556255711
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K071071
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 02/20/2018
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 Catalogue Number71453276
Initial Date Received by Manufacturer 11/16/2017
Supplement Date Received by Manufacturer11/16/2017
Initial Report FDA Received Date11/21/2017
Supplement Report FDA Received Date02/20/2018
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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