MAUDE Adverse Event Report: TORNIER INC LATITUDE ELB HUMERAL SPOOL SZPETIT SIDE GAUCHE OFFSET CENTRE; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Catalog Number	DKY212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
It was reported that, a removal of latitude ev total elbow replacement was performed for a patient who had an infection.The patient had a revision surgery on (b)(6) 2025.The surgeon accessed the joint and removed a significant amount of black matter and then proceeded to take the humeral and ulnar stem out.No further information was provided.

• Brand Name: LATITUDE ELB HUMERAL SPOOL SZPETIT SIDE GAUCHE OFFSET CENTRE
• Common Device Name: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24734944
• Report Number: 0001649390-2026-00312
• Device Sequence Number: 9286201
• Product Code: JDB
• UDI-Device Identifier: 00846832011124
• UDI-Public: (01)00846832011124(11)240804(17)290804(21)9521BA001
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K171010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DKY212
• Device Lot Number: 9521BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown