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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC LATITUDE EV ULNAR STEM PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

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TORNIER INC LATITUDE EV ULNAR STEM PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED Back to Search Results
Catalog Number UNK_WTB
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Failure of Implant (1924)
Event Date 07/19/2021
Event Type  Injury  
Manufacturer Narrative
Device not returned at time of this report. If additional information becomes available, it will be provided on a supplemental report.
 
Event Description
It was reported that the patient underwent a revision surgery for a loose ulna component.
 
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Brand NameLATITUDE EV ULNAR STEM
Type of DevicePROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
Manufacturer (Section D)
TORNIER INC
10801 nesbitt avenue s
bloomington MN 55437
Manufacturer (Section G)
TORNIER INC
10801 nesbitt avenue s
bloomington MN 55437
Manufacturer Contact
nathe hendricks
10801 nesbitt avenue s
bloomington, MN 55437
9524267600
MDR Report Key12327938
MDR Text Key266837196
Report Number3004983210-2021-00063
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 08/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_WTB
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2021
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: 08/16/2021 Patient Sequence Number: 1
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