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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CR DEEP FLEX ISRT S3-4 15M; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
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SMITH & NEPHEW, INC. GII CR DEEP FLEX ISRT S3-4 15M; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED Back to Search Results
Catalog Number 71421539
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Pain (1994); Joint Disorder (2373)
Date of Event 06/13/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery was done due to instability of knee pain.Poly was removed.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.[(b)(4)].
 
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Brand Name
GII CR DEEP FLEX ISRT S3-4 15M
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6701670
Report Number1020279-2017-00517
Device Sequence Number19154064
Product Code JWH
UDI-Device Identifier03596010520425
UDI-Public03596010520425
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K041825
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/09/2017
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 Number71421539
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/13/2017
Supplement Date Received by Manufacturer06/13/2017
Initial Report FDA Received Date07/11/2017
Supplement Report FDA Received Date10/09/2017
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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