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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MIS DCF ALIGN GDE PRSTHSISKNEE,PATLLO/FMRTIBIAL,SMI-CNSTRIND,UNCMTD,PROUS,COATD,PLYMR/MTAL/POLYMR

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SMITH & NEPHEW, INC. GII MIS DCF ALIGN GDE PRSTHSISKNEE,PATLLO/FMRTIBIAL,SMI-CNSTRIND,UNCMTD,PROUS,COATD,PLYMR/MTAL/POLYMR Back to Search Results
Catalog Number 71441144
Device Problem Device Inoperable (1663)
Patient Problem No Information (3190)
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.

 
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Brand NameGII MIS DCF ALIGN GDE
Type of DevicePRSTHSISKNEE,PATLLO/FMRTIBIAL,SMI-CNSTRIND,UNCMTD,PROUS,COATD,PLYMR/MTAL/POLYMR
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 Key7372533
MDR Text Key103664857
Report Number1020279-2018-00545
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 OTHER HEALTH CARE PROFESSIONAL
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 Received03/27/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number71441144
Device LOT Number09GM12107
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2009
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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