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 BCS II FEMORAL OXIN RT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
  • 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 BCS II FEMORAL OXIN RT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED Back to Search Results
Catalog Number 74022115
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994)
Date of Event 05/07/2015
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that patient had a revision surgery for his right knee due to pain.
 
Additional Manufacturer Narrative
(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
JRNY BCS II FEMORAL OXIN RT SZ 5
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6823350
Report Number1020279-2017-00662
Device Sequence Number13791752
Product Code JWH
UDI-Device Identifier00885556169919
UDI-Public00885556169919
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 Year2015
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date (Section B) 11/13/2017
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 Date03/05/2023
Device Catalogue Number74022115
Device Lot Number13CM04959A
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/01/2017
Supplement Date Received by Manufacturer08/01/2017
08/25/2017
08/25/2017
Initial Report FDA Received Date08/28/2017
Supplement Report FDA Received Date08/31/2017
09/01/2017
11/13/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
JOURNEY TIBIA BASE NP RT SZ 4, (B)(4); JRNY BCS PAT BICONVEX 23 MM STD, (B)(4); JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM, (B)(4)
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age68 YR
Patient Weight77
-
-