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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII C/R HA POROUS FEM SZ 5RT GENESIS II TOTAL KNEE SYSTEM

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SMITH & NEPHEW, INC. GII C/R HA POROUS FEM SZ 5RT GENESIS II TOTAL KNEE SYSTEM Back to Search Results
Catalog Number 71422030
Device Problem Corroded (1131)
Patient Problem No Code Available (3191)
Event Date 03/19/2016
Event Type  Injury  
Manufacturer Narrative

Udi#: (b)(4). Customer indicated that there is no product/device to be returned for investigation analysis.

 
Event Description

It was reported that the patient underwent a revision surgery due to product fretting and corrosion.

 
Manufacturer Narrative

Disregard; mdr 1020279-2016-00667 was filed in error. It is a duplicate of mdr 1020279-2016-00283.

 
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Brand NameGII C/R HA POROUS FEM SZ 5RT
Type of DeviceGENESIS II TOTAL KNEE SYSTEM
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
yagna angirish
1450 brooks rd
memphis, TN 38116
9013995009
MDR Report Key5903349
MDR Text Key52965509
Report Number1020279-2016-00667
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK030612
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation ATTORNEY
Type of Report Initial,Followup
Report Date 07/27/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/25/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number71422030
Device LOT Number11LM07863
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/04/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/25/2016 Patient Sequence Number: 1
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