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. LEGION PS OXIN FEM SZ2 RT; PROSTHESIS,KNEE,PATLLOFEMOROTIBIAL,SEMI-CONSTRAIND,CMNTD,POLYMR/METAL/POLYMER
  • 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. LEGION PS OXIN FEM SZ2 RT; PROSTHESIS,KNEE,PATLLOFEMOROTIBIAL,SEMI-CONSTRAIND,CMNTD,POLYMR/METAL/POLYMER Back to Search Results
Catalog Number 71421202
Medical Device Problem Code Unintended Movement (3026)
Health Effect - Clinical Code Injury (2348)
Date of Event 11/13/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to loosening.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached file for the results of our investigation.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LEGION PS OXIN FEM SZ2 RT
Common Device Name
PROSTHESIS,KNEE,PATLLOFEMOROTIBIAL,SEMI-CONSTRAIND,CMNTD,POLYMR/METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7054873
Report Number1020279-2017-01101
Device Sequence Number67589
Product Code JWH
UDI-Device Identifier00885556029787
UDI-Public00885556029787
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K043440
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date (Section B) 02/21/2018
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 Date08/19/2023
Device Catalogue Number71421202
Device Lot Number13HM15347
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/16/2017
Supplement Date Received by Manufacturer11/16/2017
11/16/2017
Initial Report FDA Received Date11/22/2017
Supplement Report FDA Received Date12/05/2017
02/21/2018
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;
-
-