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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II BICONVEX PAT 26MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
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SMITH & NEPHEW, INC. GNS II BICONVEX PAT 26MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED Back to Search Results
Catalog Number 71420568
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Loss of Range of Motion (2032)
Date of Event 08/03/2015
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported the patient presented with flexion contracture and underwent a manipulation under anesthesia.
 
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Brand Name
GNS II BICONVEX PAT 26MM
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7069959
Report Number1020279-2017-01152
Device Sequence Number11077858
Product Code JWH
UDI-Device Identifier03596010208262
UDI-Public03596010208262
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
K951987
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 03/06/2018
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 Expiration Date12/06/2024
Device Catalogue Number71420568
Device Lot Number14MM06797
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/30/2017
Supplement Date Received by Manufacturer10/30/2017
Initial Report FDA Received Date11/30/2017
Supplement Report FDA Received Date03/06/2018
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
74022127/14GM06820; 74022226/14GM06626; 74027262/12GM14457
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age51 YR
Patient Weight92
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