• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC. LATITUDE ELBOW PROSTHESIS, RADIAL STEM, 5MM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TORNIER INC. LATITUDE ELBOW PROSTHESIS, RADIAL STEM, 5MM Back to Search Results
Catalog Number DKY062
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Failure of Implant (1924)
Event Date 11/29/2018
Event Type  malfunction  
Event Description
It was identified post-operatively that the implanted latitude radial head had detached/dislodged from the implanted latitude radial stem. This resulted in a second surgical procedure (op date (b)(6) 2018) to remove the radial head prosthesis and link the current latitude elbow construct with an ulnar cap. No replacement radial head prosthesis were implanted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLATITUDE ELBOW PROSTHESIS, RADIAL STEM, 5MM
Type of DeviceELBOW PROSTHESIS
Manufacturer (Section D)
TORNIER INC.
10801 nesbitt avenue s
bloomington MN 55437
Manufacturer Contact
matt kennedy
10801 nesbitt ave s
bloomington, MN 55437
9526837482
MDR Report Key8188887
MDR Text Key131176432
Report Number3004983210-2018-00081
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K100562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 12/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberDKY062
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2018
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 Treatment Data
Date Received: 12/21/2018 Patient Sequence Number: 1
Treatment
RADIAL HEAD, MEDIUM SIZE
-
-