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

Catalog Number	DKY216
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	04/02/2026
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 total elbow replacement was done due to bone loss and loosening.No further information was provided.

• Brand Name: LATITUDE ELB HUMERAL SPOOL SZGRAND 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: 25099815
• Report Number: 0001649390-2026-00402
• Device Sequence Number: 5005363
• Product Code: JDB
• UDI-Device Identifier: 00846832011162
• UDI-Public: 00846832011162
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K070787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/11/2017
• Device Catalogue Number: DKY216
• Device Lot Number: 6646AL
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2012
• 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