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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
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SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED Back to Search Results
Catalog Number 74027262
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Hematoma (1884); Pain (1994)
Date of Event 08/25/2013
Type of Reportable Event Serious Injury
Event or Problem Description
The patient presented with left knee pain and swelling during second week post op left tka.The patient underwent an irrigation and debridement w/ liner exchange.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.
 
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Brand Name
JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6805674
Report Number1020279-2017-00642
Device Sequence Number19224077
Product Code JWH
UDI-Device Identifier00885556178010
UDI-Public00885556178010
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K111711
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2013
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date (Section B) 11/17/2017
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 Date10/23/2021
Device Catalogue Number74027262
Device Lot Number11KM14008
Initial Date Received by Manufacturer 07/24/2017
Supplement Date Received by Manufacturer07/24/2017
07/24/2017
07/24/2017
Initial Report FDA Received Date08/18/2017
Supplement Report FDA Received Date09/06/2017
09/14/2017
11/17/2017
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 Age64 YR
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