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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MIS DCF ALIGN GDE PROSTHSIS,KN,PATLLO/FMOROTIBIAL,SMI-CONSTRAIND,UNCMNTD,POROUS,COATD,POLYMR/MTAL

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SMITH & NEPHEW, INC. GII MIS DCF ALIGN GDE PROSTHSIS,KN,PATLLO/FMOROTIBIAL,SMI-CONSTRAIND,UNCMNTD,POROUS,COATD,POLYMR/MTAL Back to Search Results
Model Number 71441144
Device Problem Mechanical Problem (1384)
Patient Problem No Patient Involvement (2645)
Event Date 08/12/2020
Event Type  Malfunction  
Event Description

It was reported that the locking mechanism on the genesis ii mis dcf align gde is not working properly. This was identified during inspection after a surgical procedure. There was no mention of issues during the case and no harm to the patient.

 
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Brand NameGII MIS DCF ALIGN GDE
Type of DevicePROSTHSIS,KN,PATLLO/FMOROTIBIAL,SMI-CONSTRAIND,UNCMNTD,POROUS,COATD,POLYMR/MTAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks rd.
memphis, TN 38116
4407940038
MDR Report Key10463395
MDR Text Key204677647
Report Number1020279-2020-04268
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,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/27/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL Number71441144
Device Catalogue Number71441144
Device LOT Number13EM02390
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/11/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/03/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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