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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II ISRT XLPE DD LT SZ 5-6 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
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SMITH & NEPHEW, INC. JRNY II ISRT XLPE DD LT SZ 5-6 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED Back to Search Results
Catalog Number 74025762
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 06/11/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported a revision knee surgery was performed due to infection.The poly insert was exchanged during the procedure.
 
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
JRNY II ISRT XLPE DD LT SZ 5-6 10MM
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6690226
Report Number1020279-2017-00502
Device Sequence Number1971493
Product Code JWH
UDI-Device Identifier00885556098462
UDI-Public00885556098462
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K113482
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/05/2017
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 Number74025762
Initial Date Received by Manufacturer 06/11/2017
Supplement Date Received by Manufacturer06/11/2017
Initial Report FDA Received Date07/06/2017
Supplement Report FDA Received Date10/06/2017
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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