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 PAT BICONVEX 26 MM STD; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEM-CONSTRAIND,CEMENTD,POLYMR/METAL/POLYMR
  • 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 PAT BICONVEX 26 MM STD; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEM-CONSTRAIND,CEMENTD,POLYMR/METAL/POLYMR Back to Search Results
Catalog Number 74024626
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Injury (2348)
Date of Event 03/16/2016
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported a patient lost range of motion due to arthrofibrosis after tka and undergo manipulation under anesthesia to regain rom.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached file for our results of investigation.-(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
JRNY BCS PAT BICONVEX 26 MM STD
Common Device Name
PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEM-CONSTRAIND,CEMENTD,POLYMR/METAL/POLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7042439
Report Number1020279-2017-01058
Device Sequence Number1745191
Product Code JWH
UDI-Device Identifier03596010554475
UDI-Public03596010554475
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K042515
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) 02/20/2018
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 Date09/05/2025
Device Catalogue Number74024626
Device Lot Number15JM04464
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/10/2017
Supplement Date Received by Manufacturer11/10/2017
Initial Report FDA Received Date11/17/2017
Supplement Report FDA Received Date02/21/2018
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 Other; Required Intervention;
Patient Age65 YR
-
-