Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 RT 12MM; PRSTHSS,KNEE,PTLLFMRTBAL,SMICNSTRIND,CMNTD,PLYMRMETALPLYMR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 RT 12MM; PRSTHSS,KNEE,PTLLFMRTBAL,SMICNSTRIND,CMNTD,PLYMRMETALPLYMR Back to Search Results
Catalog Number 74027254
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); Injury (2348); Joint Swelling (2356)
Date of Event 04/24/2015
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that an infiltration with depo-medrol was performed due to hydrops.
 
Additional Manufacturer Narrative
Remaining components of the total knee involved in this event have been communicated through mdrs 1020279-2017-00985, 1020279-2017-01126 and 1020279-2017-01127.[(b)(4)].
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
JRNY II BCS XLPE ART ISRT SZ 5-6 RT 12MM
Common Device Name
PRSTHSS,KNEE,PTLLFMRTBAL,SMICNSTRIND,CMNTD,PLYMRMETALPLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7060325
Report Number1020279-2017-01125
Device Sequence Number1423423
Product Code JWH
UDI-Device Identifier00885556179512
UDI-Public00885556179512
Combination Product (Y/N)N
Initial Reporter CountryBE
PMA/510(K) Number
K111711
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 02/22/2018
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 Date10/31/2021
Device Catalogue Number74027254
Device Lot Number11LM02103
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/27/2017
Supplement Date Received by Manufacturer11/27/2017
Initial Report FDA Received Date11/27/2017
Supplement Report FDA Received Date02/22/2018
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 Weight78
-
-