MAUDE Adverse Event Report: TORNIER INC LATITUDE ULNAR STEM 75 MMMEDIUM LEFT; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Catalog Number	0030121
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/17/2025
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, the patient would require a revision surgery for failure of elbow locking mechanism.The planned date of revision was (b)(6) 2025.As no further information could be obtained, the revision surgery has been captured as it was planned.
Additional Manufacturer Narrative
The reported even could not be confirmed, although the device was returned for evaluation.No supporting imaging or medical reports were available to substantiate the event or to establish whether the damage observed on the device was attributed to a device related failure or to external causes.The device inspection revealed the following a visual inspection of the returned device indicates evidence of significant wear and use.The polymer components are detached, and exhibit areas of material removal consistent with abrasion or scraping.The titanium components display widespread sur-face damage and discoloration, with an intact cement mantle.In contrast, the screw component shows minimal evidence of wear, except for localized flattening at the crests of the threads.The damage observed to the device is most likely due to explanation but without additional information, the cause of the damage cannot be definitively deter-mined.The damage to the implant was too extensive to perform a functional or dimensional inspection.However, during manufacturing, dimensional testing was performed and the device was manufactured to specifications.Based on investigation and the lack of information provided the root cause could not be determined.However, information from the complaint reporter states surgeon reports younger male rheumatoid in 50s and i think has been at gym etc.Per the device ifu, the patient having rheumatoid arthritis is a contraindication for this implant as well as failure to follow daily precautions that could impact the lifetime of the implant by engaging in gym related activities.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 more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that, the patient would require a revision surgery for failure of elbow locking mechanism.The planned date of revision was (b)(6) 2025 2025.As no further information could be obtained, the revision surgery has been captured as it was planned.

• Brand Name: LATITUDE ULNAR STEM 75 MMMEDIUM LEFT
• Common Device Name: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork MN NA ; EI NA
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23316758
• Report Number: 0001649390-2025-00726
• Device Sequence Number: 20290356
• Product Code: JDB
• UDI-Device Identifier: 00846832002580
• UDI-Public: (01)00846832002580(11)230121(17)260121
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K171010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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 Expiration Date: 01/21/2026
• Device Catalogue Number: 0030121
• Device Lot Number: CC0722221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2023
• 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