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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC LATITUDE ELBOW SYSTEM LATITUDE ELBOW PROTHESIS

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TORNIER INC LATITUDE ELBOW SYSTEM LATITUDE ELBOW PROTHESIS Back to Search Results
Catalog Number UNAVAILABLE
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
Source - article: saurabh s. Mehta, frcs (ed) tr, orth, adam c. Watts, frcs (tr, orth), sumedh c. Talwalkar, frcs (tr, orth), ann birch, msc, david nuttall, phd, ian a. Trail, md*, early results of latitude primary total elbow replacement with a minimum follow-up of 2 years. Journal of shoulder and elbow surgery 2017, vol. ?? - [(b)(4)].
 
Event Description
It was reported in a 2017 journal article from mehta, et al. , out of eight latitude revision cases, two were revised due to aseptic loosening. Source - article: saurabh s. Mehta, frcs (ed) tr, orth, adam c. Watts, frcs (tr, orth), sumedh c. Talwalkar, frcs (tr, orth), ann birch, msc, david nuttall, phd, ian a. Trail, md*, early results of latitude primary total elbow replacement with a minimum follow-up of 2 years. Journal of shoulder and elbow surgery 2017, vol. ??.
 
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Brand NameLATITUDE ELBOW SYSTEM
Type of DeviceLATITUDE ELBOW PROTHESIS
Manufacturer (Section D)
TORNIER INC
10801 nesbitt avenue s
bloomington MN 55437
Manufacturer Contact
mary mcnabb
4375 e park 30 drive
columbia city, IN 46725
5743713153
MDR Report Key9285684
MDR Text Key165306983
Report Number3004983210-2019-00100
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 literature
Reporter Occupation
Type of Report Initial
Report Date 11/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNAVAILABLE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2019
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 Unkown

Patient Treatment Data
Date Received: 11/06/2019 Patient Sequence Number: 1
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