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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HINGE TIBIAL STABILIZING TOOL TOTAL KNEE SYSTEM INSTRUMENTATION

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SMITH & NEPHEW, INC. LEGION HINGE TIBIAL STABILIZING TOOL TOTAL KNEE SYSTEM INSTRUMENTATION Back to Search Results
Catalog Number 71434465
Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212)
Patient Problem No Code Available (3191)
Event Date 05/10/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported the instrument stem snapped off and became stuck in implant. No revision is planned to remove component in patient as of date.

 
Manufacturer Narrative

The associated complaint device was returned and evaluated. A visual inspection found the peg/connector is broken off, but the broken piece was not returned with the device. The device exhibits signs of wear/usage. The manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident. The device was manufactured in 2013. A review of complaint history revealed no prior complaints for the listed lot or failure mode. The clinical/medical team concluded, no injury or impact to patient is being reported. Additionally, the device was not returned for evaluation. No further clinical assessment is warranted at this time. We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary. At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture. This investigation could not verify or identify any evidence of product contribution to the reported problem. Based on this investigation, the need for corrective action is not indicated. Should additional information be received, the complaint will be reopened.

 
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Brand NameLEGION HINGE TIBIAL STABILIZING TOOL
Type of DeviceTOTAL KNEE SYSTEM INSTRUMENTATION
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
yagna angirish
1450 brooks rd
memphis, TN 38116
9013995009
MDR Report Key5688804
MDR Text Key46207100
Report Number1020279-2016-00433
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUK
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 05/10/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/31/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number71434465
Device LOT Number13FEM0024
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/14/2013
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: 05/31/2016 Patient Sequence Number: 1
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