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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 3-4 11; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 3-4 11; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL Back to Search Results
Catalog Number 71421509
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Injury (2348)
Date of Event 02/16/2018
Type of Reportable Event Serious Injury
Event or Problem Description
Revision surgery was performed due to hematoma.The surgeon decided it is not the product failure.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.No clinical supporting documents were provided to conduct a thorough analysis of the reported issue.Per the surgeon, this issue is not the device related.No further actions are being taken at this time.Should additional information be received, the complaint will be reopened.
 
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Brand Name
GII PS HI FLEX ISRT SZ 3-4 11
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7325702
Report Number1020279-2018-00289
Device Sequence Number16545556
Product Code JWH
UDI-Device Identifier03596010492364
UDI-Public03596010492364
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K032295
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Device Explanted Year2018
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 05/21/2018
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 Number71421509
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/20/2018
Supplement Date Received by Manufacturer02/20/2018
Initial Report FDA Received Date03/08/2018
Supplement Report FDA Received Date05/21/2018
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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