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. LGN HK FEM ASSEMBLY SZ 7 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, 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. LGN HK FEM ASSEMBLY SZ 7 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 71421367
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Swelling (2091)
Date of Event 09/15/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported an medical intervention due to weight bearing pain and swelling of the knee.Surgeon noted that adverse event may be related to study procedure.
 
Additional Manufacturer Narrative
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please review attached for investigation results.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LGN HK FEM ASSEMBLY SZ 7 RT
Common Device Name
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6994901
Report Number1020279-2017-00963
Device Sequence Number1051296
Product Code KRO
UDI-Device Identifier00885556414927
UDI-Public00885556414927
Combination Product (Y/N)N
PMA/510(K) Number
K081111
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date (Section B) 01/05/2018
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 No Information
Device Expiration Date07/18/2022
Device Catalogue Number71421367
Device Lot Number15GM04619
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/04/2017
Supplement Date Received by Manufacturer10/04/2017
10/04/2017
Initial Report FDA Received Date11/01/2017
Supplement Report FDA Received Date11/03/2017
01/05/2018
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;
Patient Age52 YR
Patient Weight278
-
-