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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 5 {} LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
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SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 5 {} LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED Back to Search Results
Catalog Number 71420168
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Aspiration/Inhalation (1725); Pain (1994)
Date of Event 12/07/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported the patient presented with pain and underwent aspiration of the knee and nerve block ablation in the knee.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.[(b)(4)].
 
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Brand Name
GNS II CMT TIB SIZE 5 {} LEFT
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7109898
Report Number1020279-2017-01233
Device Sequence Number94317
Product Code JWH
UDI-Device Identifier03596010206275
UDI-Public03596010206275
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K951987
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Patient
Type of Report Initial,Followup
Report Date (Section B) 03/18/2018
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 Number71420168
Device Lot Number16LM09514
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/12/2017
Supplement Date Received by Manufacturer12/12/2017
Initial Report FDA Received Date12/12/2017
Supplement Report FDA Received Date03/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
71420576/16MM01226; 71421236/16EM04536; 71453284/16HM16676
Outcome Attributed to Adverse Event Required Intervention;
Patient Age74 YR
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