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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNEE IMPLANT PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

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SMITH & NEPHEW, INC. KNEE IMPLANT PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY Back to Search Results
Device Problem Insufficient Information
Event Date 02/09/2018
Event Type  Injury  
Event Description

It was reported that revision surgery was performed due to an infection. Device information is still missing.

 
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Brand NameKNEE IMPLANT
Type of DevicePROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
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
sarah freestone
1450 brooks road
memphis , TN 38116
0447940038
MDR Report Key8746918
Report Number1020279-2019-02597
Device Sequence Number1
Product CodeJWH
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,STUDY,USE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 06/30/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2019
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: 06/30/2019 Patient Sequence Number: 1
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