MAUDE Adverse Event Report: TORNIER INC LATITUDE ELBOW RADIAL HEAD MODEL MOYEN; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Catalog Number	DKY057
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received a report from the national joint registry that contains unpublished collected data on the usage and the outcomes of the elbow joint replacement.The report details analysis provided for revision procedures performed until (b)(6) 2026.During the review of the report, it was identified that on (b)(6) 2025, a patient required revision surgery due to infection, which was not previously reported to the manufacturer.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation, and no other additional information was received from the national joint registry.More detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.Please note, that reports received from the national joint registry are not published reports and therefore web link is not available.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history was not necessary because the implant affected by this complaint has been manufactured in 2020.As a result, this implant is expired and can no longer be put on the market or implanted.The complaint history review found no other complaint recorded for this lot number.Moreover, the post market surveillance reviews have not identified any signals for similar issues that would have challenged the efficacy and safety of this product.Surgical site infections (ssis) are a well-documented and relatively common complication following surgical procedures, with a global incidence of approximately 11% in general surgeries (gillespie, et al., 2021).In trauma surgeries, the risk is often elevated due to factors such as emergency conditions, open fractures, and limited time for optimal preoperative preparation.While it is theoretically possible for an infection to stem from a breach in the sterilization process at the manufacturing site, such occurrences are highly unlikely given the rigorous quality control systems, validated sterilization methods, and multiple checkpoints in place.More commonly, infections may arise from breaches in sterile techniques during handling, storage, or surgery itself- such as compromised packaging, improper transfer of the implant, or contamination during the procedure.Another main cause of post-operative wound infections (superficial and deep) may be related to post-operative factors, such as the open wound (even when closed with stitches/ staples), wound care/ hygiene, swelling/edema (inflammation), post-operative hematoma, etc.Additionally, patient-related factors, including their own microbiome, represent a significant and often unavoidable source of infection.A review of the labeling did not indicate any abnormalities.The nature of the complaint doesn¿t necessitate a drawing review.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
The manufacturer received a report from the national joint registry that contains unpublished collected data on the usage and the outcomes of the elbow joint replacement.The report details analysis provided for revision procedures performed until (b)(6) 2026.During the review of the report, it was identified that on (b)(6) 2025, a patient required revision surgery due to infection, which was not previously reported to the manufacturer.

• Brand Name: LATITUDE ELBOW RADIAL HEAD MODEL MOYEN
• 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: 24558919
• Report Number: 0001649390-2026-00269
• Device Sequence Number: 9440320
• Product Code: JDB
• UDI-Device Identifier: 00846832010943
• UDI-Public: 00846832010943
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K100562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: DKY057
• Device Lot Number: 2756AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 05/15/2026
• 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 Age: 69 YR
• Patient Sex: Female
• Patient Weight: 101 KG