MAUDE Adverse Event Report: TORNIER INC LATITUDE ELBOW ULNAR CAP MODEL PETIT; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Catalog Number	DKY067
Medical Device Problem Codes	Break (1069); Fracture (1260); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Loss of fracture reduction (4901)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, the custom long length ulnar stem with no bony support around the olecranon (stress riser) broke at the bone stem junction.Revision procedure required to reimplant another long stem ulnar component with allograft bony support.Revision due to broken ulnar stem.Revision procedure was successful.No x rays available at the moment.No further information was available.
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that, the custom long length ulnar stem with no bony support around the olecranon (stress riser) broke at the bone stem junction.Revision procedure required to reimplant another long stem ulnar component with allograft bony support.Revision due to broken ulnar stem.Revision procedure was successful.No x rays available at the moment.No further information was available.
Additional Manufacturer Narrative
Correction: section d9 (return status updated to no) and h6 (device code corrected from break to fracture).The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LATITUDE ELBOW ULNAR CAP MODEL PETIT
• 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: 22787731
• Report Number: 0001649390-2025-00556
• Device Sequence Number: 15485781
• Product Code: JDB
• UDI-Device Identifier: 00846832010905
• UDI-Public: (01)00846832010905(21)9929AK014
• 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 Implanted Year: 2013
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2025

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: DKY067
• Device Lot Number: 9929AK
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2012
• 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