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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. HLS NOETOS FEMORAL IMPLANT; PROSTHESIS KNEE JOINT CEMENTED METAL
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TORNIER S.A.S. HLS NOETOS FEMORAL IMPLANT; PROSTHESIS KNEE JOINT CEMENTED METAL Back to Search Results
Model Number SIZE 2 LEFT
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 05/17/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
 
Event or Problem Description
Revision for tibial loosening after 3 years.Explant analysis during revision shows that the keel of the tibial is only partially cemented.
 
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
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Brand Name
HLS NOETOS FEMORAL IMPLANT
Common Device Name
PROSTHESIS KNEE JOINT CEMENTED METAL
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint-martin, 38330
FR  38330
MDR Report Key6656126
Report Number3000931034-2017-00129
Device Sequence Number11148275
Product Code JWH
UDI-Device Identifier03700386912375
UDI-Public03700386912375
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K013906
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2017
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 05/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Physician
Device Expiration Date04/30/2018
Device Model NumberSIZE 2 LEFT
Device Catalogue NumberGDF702
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2017
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 05/24/2017
Supplement Date Received by Manufacturer05/24/2017
Initial Report FDA Received Date06/21/2017
Supplement Report FDA Received Date01/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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