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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 7 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
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SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 7 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META Back to Search Results
Catalog Number 71420172
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Injury (2348)
Date of Event 12/07/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the clinical subject experienced decreased range of motion on the study knee.The event was treated via surgery and is considered resolved.
 
Additional Manufacturer Narrative
This is a duplicate report.Please consider report 1020279-2020-02507 for any future references.
 
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Brand Name
GNS II CMT TIB SIZE 7 LEFT
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key10080591
Report Number1020279-2020-01825
Device Sequence Number3792121
Product Code JWH
UDI-Device Identifier03596010206299
UDI-Public3596010206299
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K951987
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,o
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/18/2020
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 Date03/03/2019
Device Catalogue Number71420172
Device Lot Number09CM03387
Initial Date Received by Manufacturer 04/27/2020
Supplement Date Received by Manufacturer04/27/2020
Initial Report FDA Received Date05/21/2020
Supplement Report FDA Received Date06/18/2020
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;
Patient Weight110
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