MAUDE Adverse Event Report: Tornier Inc LATITUDE ELBOW ULNAR CAP MODEL GRAND; Prosthesis, elbow, semi-constrained, cemented

Catalog Number	DKY069
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	05/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "infection elbow prosthesis total elbow arthroplasty initial - irrigation and debridement periprosthetic infection right elbow with removal of ulnar implant and insertion of antibiotic impregnated methylmethacrylate cement beads (tobramycin, vancomycin, and ancef).The tentative plan will be to treat the patient with 6 weeks of antibiotics intravenously and then plan staged revision.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.

• Brand Name: LATITUDE ELBOW ULNAR CAP MODEL GRAND
• Common Device Name: Prosthesis, elbow, semi-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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50176688
• Report Number: 0001649390-2026-00787
• Device Sequence Number: 8354709
• Product Code: JDB
• UDI-Device Identifier: 00846832010929
• UDI-Public: 00846832010929
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K070787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: DKY069
• Device Lot Number: 5820AX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male