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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GENESIS FEMORAL COMPONENT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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SMITH & NEPHEW, INC. GENESIS FEMORAL COMPONENT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Sepsis (2067)
Event Date 02/20/2017
Event Type  Injury  
Event Description

It was reported that surgeon took out a total knee because the patient got septic because off sinus on leg. Surgeon took the implants out and put a spacer in.

 
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Brand NameGENESIS FEMORAL COMPONENT
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 de santis
schachenallee 29
aarau 5001
SZ   5001
0628320660
MDR Report Key6371334
MDR Text Key68750101
Report Number1020279-2017-00145
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeSF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/02/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2017
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: 03/02/2017 Patient Sequence Number: 1
Treatment
GENESIS CONSTRAIN POLY INSERT, PART&LOT#:UNKNOWN; GENESIS TIBIAL COMPONENT, PART&LOT#:UNKNOWN
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