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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION TRL STEM CONNECTION ROD PRST,KN,PAT/FEM,SEMCNSTR,UNCM,POR,COAT,POL/MET/POL

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SMITH & NEPHEW, INC. LEGION TRL STEM CONNECTION ROD PRST,KN,PAT/FEM,SEMCNSTR,UNCM,POR,COAT,POL/MET/POL Back to Search Results
Model Number 71434317
Device Problem Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Date 08/27/2020
Event Type  Malfunction  
Event Description

It was reported that during inspection process was found that the legion trial stem connection rod has stripped threads. There was no case involved.

 
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Brand NameLEGION TRL STEM CONNECTION ROD
Type of DevicePRST,KN,PAT/FEM,SEMCNSTR,UNCM,POR,COAT,POL/MET/POL
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
holly topping
1450 brooks rd.
memphis, TN 38116
5123913905
MDR Report Key10571901
MDR Text Key208088845
Report Number1020279-2020-04819
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
Reporter Occupation
Type of Report Initial
Report Date 09/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/23/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL Number71434317
Device Catalogue Number71434317
Device LOT Number12DM02627
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/04/2012
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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