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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II NON-POR TIB SZ 7 RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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SMITH & NEPHEW, INC. GNS II NON-POR TIB SZ 7 RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL Back to Search Results
Model Number 71420190
Medical Device Problem Code Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 08/06/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that, after a total knee arthroplasty (conducted on an unknown date), a genesis ii non-porous tibial size 7 right and a legion posterior stabilized high flex highly cross linked polyethylene size 7-8 9mm were suspected of loosening.The adverse event was treated with a revision surgery on (b)(6) 2021.Patient outcome is unknown.
 
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Brand Name
GNS II NON-POR TIB SZ 7 RIGHT
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key12343622
Report Number1020279-2021-06486
Device Sequence Number3593749
Product Code JWH
UDI-Device Identifier03596010206374
UDI-Public03596010206374
Combination Product (Y/N)N
Initial Reporter CountryGM
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2021
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 09/24/2021
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? Yes
Operator of Device Health Professional
Device Model Number71420190
Device Catalogue Number71420190
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 08/07/2021
Supplement Date Received by Manufacturer09/23/2021
Initial Report FDA Received Date08/19/2021
Supplement Report FDA Received Date09/24/2021
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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