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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II RESURF PAT 29MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTD,POLYMR/METAL/POLYMR
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SMITH & NEPHEW, INC. GNS II RESURF PAT 29MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTD,POLYMR/METAL/POLYMR Back to Search Results
Catalog Number 71420574
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Unspecified Infection (1930); Injury (2348)
Date of Event 08/31/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported a revision knee surgery was performed due to infection.
 
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Please see attached file for our results of investigation.(b)(4).
 
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Brand Name
GNS II RESURF PAT 29MM
Common Device Name
PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTD,POLYMR/METAL/POLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6883501
Report Number1020279-2017-00782
Device Sequence Number1364608
Product Code JWH
UDI-Device Identifier03596010208293
UDI-Public03596010208293
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K951987
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 11/30/2017
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 Date09/20/2026
Device Catalogue Number71420574
Device Lot Number16JM11765
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/06/2017
Supplement Date Received by Manufacturer09/06/2017
Initial Report FDA Received Date09/21/2017
Supplement Report FDA Received Date11/30/2017
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; Other; Required Intervention;
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