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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OFFSET COUPLER TRIAL 6MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS

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SMITH & NEPHEW, INC. LGN OFFSET COUPLER TRIAL 6MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS Back to Search Results
Catalog Number 71434306
Device Problem Fracture (1260)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/25/2018
Event Type  Injury  
Event Description

Dr needed to remove the trial, using the slap hammer, dr realized the femoral component came away from the bone, without the stem and offset coupler. On investigation we realized the coupler had broken, part in the femoral trial and part in the trial stem in the medullary canal. He needed to remove some bone from the anterior cortex to gain access to the end of the construct to enable him to grip it with bone nibblers and remove it. On further examination we realized the locking screw in the coupler had fractured.

 
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Brand NameLGN OFFSET COUPLER TRIAL 6MM
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS
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
101 hessle road
hull HU3 2-BN
UK   HU3 2BN
MDR Report Key7688786
MDR Text Key114003104
Report Number1020279-2018-01295
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 09/12/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number71434306
Device LOT Number06CM17127
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 Received06/24/2018
Was Device Evaluated By Manufacturer? Yes
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: 07/15/2018 Patient Sequence Number: 1
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