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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER, INC LATITUDE TOTAL ELBOW SYSTEM; ELBOW PROSTHESIS

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TORNIER, INC LATITUDE TOTAL ELBOW SYSTEM; ELBOW PROSTHESIS Back to Search Results
Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Type  malfunction  
Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.
 
Event Description
Between 2006 and 2008 a total of 19 men and 50 women underwent tea (total elbow arthroplasty) surgery.13 (31%) of the patients experienced disengagement of the radial head component with a radial head component implanted.Article citation: bone joint j 2015; 97-b:681-8.Radial head (rh) disengagement may be due to the surgical technique with a high placement.The rh may have been implanted too high as there is no guide in the latitude legacy instrument set; thus, the surgeon, dr.(b)(6) believes that there is a possibility of over stuffing and thus leading to the dislocation of the head and the stem.According to dr.De vos the results of this article are only based on the latitude system and not latitude ev.Dr.(b)(6) stated that all cases were asymptomatic and no cases were revised because of the rh.Only one rh case was revised, but only to link the prosthesis, there was no relation to the rh.
 
Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
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Brand Name
LATITUDE TOTAL ELBOW SYSTEM
Type of Device
ELBOW PROSTHESIS
Manufacturer (Section D)
TORNIER, INC
10801 nesbitt ave south
bloomington MN 55437
Manufacturer (Section G)
TORNIER, INC.
10801 nesbitt ave south
bloomington MN 55437
Manufacturer Contact
kevin smith
10801 nesbitt ave south
bloomington, MN 55437
9529217121
MDR Report Key5015225
MDR Text Key24594385
Report Number3004983210-2015-00016
Device Sequence Number1
Product Code JDB
Combination Product (y/n)N
PMA/PMN Number
K100562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation Physician
Type of Report Followup
Report Date 11/20/2015
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? No
Device Operator Physician
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/19/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/14/2015
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 N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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