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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GENESIS II CEMENTED TIBIAL SIZE 5 LEFT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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SMITH & NEPHEW, INC. GENESIS II CEMENTED TIBIAL SIZE 5 LEFT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Model Number 71420168
Device Problems Failure To Adhere Or Bond (1031); Metal Shedding Debris (1804)
Patient Problem No Code Available (3191)
Event Date 08/18/2016
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that a revision surgery was performed with exchange of tibial tray and articular component due to loosening. Surgeon booked the surgery for a poly exchange. Intraoperatively he discovered extensive metallosis in the surrounding tissues and that the tibial tray was loose.

 
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Brand NameGENESIS II CEMENTED TIBIAL SIZE 5 LEFT
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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
claudia odoy
schachenallee 29
aarau 5001
SZ   5001
0628320660
MDR Report Key5910274
MDR Text Key53337543
Report Number1020279-2016-00671
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeSF
PMA/PMN NumberK951987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/22/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number71420168
Device Catalogue Number71420168
Device LOT Number13AT27576
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/25/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/29/2016 Patient Sequence Number: 1
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