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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. SALTO TALARIS ANKLE PROSTHESIS
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TORNIER S.A.S. SALTO TALARIS ANKLE PROSTHESIS Back to Search Results
Model Number UNKNOWN
Device Problem Missing Value Reason (3192)
Patient Problem Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
Analysis of an article "a controlled, comparative study of a fixed-bearing versus mobile-bearing ankle arthroplasty" gaudot f, colombier ja, bonnin m,and judet t., foot ankle int.2014 feb;35(2):131-40.This is the final report submitted regarding this surgical event and medical device.
 
Event Description
1 patient was revised and fused due to secondary osteonecrosis of the talar component after 28 month.
 
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Brand Name
SALTO TALARIS ANKLE PROSTHESIS
Type of Device
SALTO TALARIS ANKLE PROSTHESIS
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint martin, 38330
FR  38330
Manufacturer Contact
segolene pollet
161 rue lavoisier
montbonnot saint martin, 38330
FR   38330
76613500
MDR Report Key5250898
MDR Text Key32155866
Report Number3000931034-2015-00197
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K130533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation Other
Type of Report Initial
Report Date 11/09/2015
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? Yes
Device Operator Health Professional
Device Model NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/09/2015
Initial Date FDA Received11/25/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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