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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HIGH FLEXION INSERT SZ 3-4 18MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
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SMITH & NEPHEW, INC. GII PS HIGH FLEXION INSERT SZ 3-4 18MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY Back to Search Results
Catalog Number 71421512
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Injury (2348)
Date of Event 02/26/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery has been performed.Left femoral component was explanted.
 
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and no relevant clinical medical information was provided to conduct a thorough medical assessment.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
 
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Brand Name
GII PS HIGH FLEXION INSERT SZ 3-4 18MM
Common Device Name
PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8434476
Report Number1020279-2019-01108
Device Sequence Number19245187
Product Code JWH
UDI-Device Identifier03596010492944
UDI-Public03596010492944
Combination Product (Y/N)N
Initial Reporter CountrySF
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/20/2019
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 Catalogue Number71421512
Initial Date Received by Manufacturer 02/26/2019
Supplement Date Received by Manufacturer02/26/2019
Initial Report FDA Received Date03/19/2019
Supplement Report FDA Received Date06/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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