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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 7-8 LT 9MM; PRSTHSS,KNEE,PTLLFMRTBL,SMICNSTRND,CMNTD,PLYMR/MTAL/PLYMR
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SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM; PRSTHSS,KNEE,PTLLFMRTBL,SMICNSTRND,CMNTD,PLYMR/MTAL/PLYMR Back to Search Results
Catalog Number 74027281
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); Swelling (2091)
Date of Event 09/01/2015
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a surgical intervention was performed due to left knee pain and swelling.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.[(b)(4)].
 
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Brand Name
JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM
Common Device Name
PRSTHSS,KNEE,PTLLFMRTBL,SMICNSTRND,CMNTD,PLYMR/MTAL/PLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7015641
Report Number1020279-2017-00992
Device Sequence Number1901233
Product Code JWH
UDI-Device Identifier00885556178317
UDI-Public00885556178317
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K111711
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 02/13/2018
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 Date04/09/2025
Device Catalogue Number74027281
Device Lot Number15DM07455
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/30/2017
Supplement Date Received by Manufacturer10/30/2017
Initial Report FDA Received Date11/09/2017
Supplement Report FDA Received Date02/13/2018
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 Age66 YR
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