MAUDE Adverse Event Report: TORNIER INC LATITUDE EV ULNAR STEM 75 MM MEDIUM RIGHT; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Catalog Number	0030120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device remains implanted in patient.
Event or Problem Description
It was reported in a clinical study that there was intraoperative complication that occurred during the surgery.Probable small cortical perforation leading to cement leakage while placing ulnar component.This event was reported with a causal relationship to the surgical procedure.No actions were needed to address the issues because cement causing no symptom so not removed.

• Brand Name: LATITUDE EV ULNAR STEM 75 MM MEDIUM RIGHT
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18351892
• Report Number: 0001649390-2023-00347
• Device Sequence Number: 15557495
• Product Code: JDB
• UDI-Device Identifier: 00846832002573
• UDI-Public: 00846832002573
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K171010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2023

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: Health Professional
• Device Catalogue Number: 0030120
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 53 KG