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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 13; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
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SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 3-4 13; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED Back to Search Results
Catalog Number 71421510
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Pain (1994); Injury (2348)
Date of Event 07/12/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a knee revision was performed to remove and replace insert due to pain.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached the results of our investigation.(b)(4).
 
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Brand Name
GII PS HI FLEX ISRT SZ 3-4 13
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6784450
Report Number1020279-2017-00615
Device Sequence Number16363302
Product Code JWH
UDI-Device Identifier03596010492920
UDI-Public03596010492920
Combination Product (Y/N)N
Initial Reporter CountrySF
PMA/510(K) Number
K032295
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/10/2017
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 Expiration Date02/10/2024
Device Catalogue Number71421510
Device Lot Number14BM09132
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 07/12/2017
Supplement Date Received by Manufacturer07/12/2017
Initial Report FDA Received Date08/10/2017
Supplement Report FDA Received Date10/10/2017
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;
Patient Age63 YR
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