• 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 MIS DCF ALIGN GDE PROS, KNEE, PAT/FEM, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED

  • 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 MIS DCF ALIGN GDE PROS, KNEE, PAT/FEM, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED Back to Search Results
Catalog Number 71441144
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Event Description

A device malfunction was identified that, upon reoccurrence, may necessitate medical intervention and/or result in an extended surgical delay.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGII MIS DCF ALIGN GDE
Type of DevicePROS, KNEE, PAT/FEM, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
robert rust
1450 brooks road
memphis, TN 38116
MDR Report Key7371683
MDR Text Key103673232
Report Number1020279-2018-00521
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/26/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number71441144
Device LOT Number15DM04765
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/23/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-