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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL RESURFACING PAT 35MM; PROSTH, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY
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SMITH & NEPHEW, INC. GII OVAL RESURFACING PAT 35MM; PROSTH, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY Back to Search Results
Model Number 71421035
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); Injury (2348)
Date of Event 01/10/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the clinical subject experienced left knee hemarthrosis and cellulitis.The event was resolved via revision surgery.The event is considered ongoing.
 
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Brand Name
GII OVAL RESURFACING PAT 35MM
Common Device Name
PROSTH, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9997281
Report Number1020279-2020-01373
Device Sequence Number14411935
Product Code JWH
UDI-Device Identifier03596010485076
UDI-Public03596010485076
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K951987
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source health professional,study,use
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 12/15/2020
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 Model Number71421035
Device Catalogue Number71421035
Device Lot Number17KM06062
Initial Date Received by Manufacturer 04/02/2020
Supplement Date Received by Manufacturer12/13/2020
Initial Report FDA Received Date04/24/2020
Supplement Report FDA Received Date12/16/2020
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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