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. GII PS INSERT SZ 7-8 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
  • 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. GII PS INSERT SZ 7-8 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED Back to Search Results
Catalog Number 71420844
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Injury (2348); Joint Dislocation (2374)
Date of Event 06/29/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a knee revision was performed due to a disengaged poly.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached the results of our investigation.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GII PS INSERT SZ 7-8 9MM
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6746826
Report Number1020279-2017-00564
Device Sequence Number188001
Product Code JWH
UDI-Device Identifier03596010209719
UDI-Public03596010209719
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K951987
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/06/2017
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 Date07/26/2026
Device Catalogue Number71420844
Device Lot Number16GM19024
Initial Date Received by Manufacturer 06/29/2017
Supplement Date Received by Manufacturer06/29/2017
Initial Report FDA Received Date07/27/2017
Supplement Report FDA Received Date10/07/2017
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;
-
-