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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II BICONVEX PAT 23MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,PLYMR/METAL/PLYMR
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SMITH & NEPHEW, INC. GNS II BICONVEX PAT 23MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,PLYMR/METAL/PLYMR Back to Search Results
Model Number 71420566
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Injury (2348)
Date of Event 04/08/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to dislocation.The doctor says the device was not defect but the angle was not appropriate.
 
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Brand Name
GNS II BICONVEX PAT 23MM
Common Device Name
PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,PLYMR/METAL/PLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key10022686
Report Number1020279-2020-01448
Device Sequence Number11466289
Product Code JWH
UDI-Device Identifier03596010208255
UDI-Public03596010208255
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K951987
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 12/10/2020
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 Model Number71420566
Device Catalogue Number71420566
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/08/2020
Supplement Date Received by Manufacturer12/09/2020
Initial Report FDA Received Date05/04/2020
Supplement Report FDA Received Date12/10/2020
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 Age78 YR
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