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 NP FEM SZ 6 RT; PRSTHSISKNEEPTELLFMORTIBLSMICNSTRINDCMNTDPLYMRMTALPLYMR
  • 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 NP FEM SZ 6 RT; PRSTHSISKNEEPTELLFMORTIBLSMICNSTRINDCMNTDPLYMRMTALPLYMR Back to Search Results
Model Number 71423236
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); Injury (2348)
Date of Event 03/16/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that apparently patient knee never settled and caused him pain.Surgeon suspected a low-grade infection but lab tests could not confirm it.Patient had a second revision surgery to remove the implant and insert a cement spacer.Primary knee replacement performed on the (b)(6) 2019.On the (b)(6) 2019 patient had a first revision surgery to exchange the poly and perform a washout (this event was reported at the time).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LEGION PS NP FEM SZ 6 RT
Common Device Name
PRSTHSISKNEEPTELLFMORTIBLSMICNSTRINDCMNTDPLYMRMTALPLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9938667
Report Number1020279-2020-01236
Device Sequence Number654682
Product Code JWH
UDI-Device Identifier00885556031001
UDI-Public00885556031001
Combination Product (Y/N)N
Initial Reporter CountrySF
PMA/510(K) Number
K060742
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) 08/25/2021
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 Model Number71423236
Device Catalogue Number71423236
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/16/2020
Supplement Date Received by Manufacturer08/25/2021
Initial Report FDA Received Date04/08/2020
Supplement Report FDA Received Date08/25/2021
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;
-
-