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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII TIBIAL ALIGNMENT TUBE PRSTHSIS,KNEE,PATLLO/FMRTIBL,SMI-CNSTRND,UNCMNTD,PORS,COATD,POLYMR/MTAL/POLYMR

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SMITH & NEPHEW, INC. GII TIBIAL ALIGNMENT TUBE PRSTHSIS,KNEE,PATLLO/FMRTIBL,SMI-CNSTRND,UNCMNTD,PORS,COATD,POLYMR/MTAL/POLYMR Back to Search Results
Catalog Number 71440448
Device Problem Difficult To Position (1467)
Patient Problem Injury (2348)
Event Date 03/23/2018
Event Type  Injury  
Event Description

It was reported that the tibial alignment guide couldn't be closed before fixing with pins, so the surgeon had proceed with a recut.

 
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Brand NameGII TIBIAL ALIGNMENT TUBE
Type of DevicePRSTHSIS,KNEE,PATLLO/FMRTIBL,SMI-CNSTRND,UNCMNTD,PORS,COATD,POLYMR/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
sarah freestone
1450 brooks road
memphis, TN 38116
MDR Report Key7489673
MDR Text Key107434683
Report Number1020279-2018-00882
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeBE
PMA/PMN NumberK121393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number71440448
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 Received04/12/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 05/07/2018 Patient Sequence Number: 1
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