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. GNS II RESURF PAT 29MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY
  • 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. GNS II RESURF PAT 29MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY Back to Search Results
Catalog Number 71420574
Medical Device Problem Codes Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994)
Date of Event 11/09/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported a revision surgery to replace the knee's patella due to dislodgement of the implant.
 
Additional Manufacturer Narrative
[(b)(4)].
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GNS II RESURF PAT 29MM
Common Device Name
PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7053459
Report Number1020279-2017-01090
Device Sequence Number10784635
Product Code JWH
UDI-Device Identifier03596010208293
UDI-Public03596010208293
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K951987
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 03/14/2018
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 Date09/23/2022
Device Catalogue Number71420574
Device Lot Number12JM14733
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 11/13/2017
Supplement Date Received by Manufacturer11/13/2017
Initial Report FDA Received Date11/22/2017
Supplement Report FDA Received Date03/14/2018
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; Required Intervention;
Patient Age70 YR
-
-