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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC. LATITUDE ELBOW PROSTHESIS, HUMERAL SPOOL, SMALL, RIGHT, CENTERED
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TORNIER INC. LATITUDE ELBOW PROSTHESIS, HUMERAL SPOOL, SMALL, RIGHT, CENTERED Back to Search Results
Catalog Number DKY211
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 07/28/2016
Event Type  Injury  
Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
Event Description
It was reported that the implanted latitude was removed from the patient's right shoulder due to infection.A new device was placed.No further patient complications have been reported.
 
Event Description
It was reported that the implanted latitude was removed from the patient's right elbow due to infection.A new device was placed.No further patient complications have been reported.
 
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Brand Name
LATITUDE ELBOW PROSTHESIS, HUMERAL SPOOL, SMALL, RIGHT, CENTERED
Type of Device
ELBOW PROSTHESIS
Manufacturer (Section D)
TORNIER INC.
10801 nesbit avenue south
bloomington MN 55437
Manufacturer Contact
dustin smith
10801 nesbit ave south
bloomington, MN 55437
9529217121
MDR Report Key5864943
MDR Text Key51736380
Report Number3004983210-2016-00033
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date04/01/2020
Device Catalogue NumberDKY211
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/01/2016
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
Treatment
RADIAL HEAD, SMALL
Patient Outcome(s) Required Intervention;
Patient Age71 YR
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