MAUDE Adverse Event Report: TORNIER S.A.S. CEMENT RESTRICTOR DIA.13MM; CEMENT OBTURATOR

Catalog Number	EBO102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	03/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject:(b)(6)- welbow clinical study.Post-operative complication: ¿fracture of any part of the operated arm¿ five years after the initial surgery involving the latitude ev implant, the patient presented to their local general practitioner with pain and swelling in the right elbow.An x-ray confirmed the presence of a periprosthetic fracture.The outcome was reported as ¿ongoing¿.A back slab was applied for immobilization, and further x-rays will be conducted to monitor the healing progress and evaluate the outcome.
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.
Event or Problem Description
Subject: (b)(6) - welbow clinical study.Post-operative complication: ¿fracture of any part of the operated arm¿ five years after the initial surgery involving the latitude ev implant, the patient presented to their local general practitioner with pain and swelling in the right elbow.An x-ray confirmed the presence of a periprosthetic fracture.The outcome was reported as ¿ongoing¿.A back slab was applied for immobilization, and further x-rays will be conducted to monitor the healing progress and evaluate the outcome.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.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: CEMENT RESTRICTOR DIA.13MM
• Common Device Name: CEMENT OBTURATOR
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20096504
• Report Number: 3000931034-2024-00509
• Device Sequence Number: 8571943
• Product Code: LZN
• UDI-Device Identifier: 03700386928710
• UDI-Public: 03700386928710
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K061824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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: 04/12/2023
• Device Catalogue Number: EBO102
• Device Lot Number: 6058AT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2018
• 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: Disability; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male