MAUDE Adverse Event Report: TORNIER S.A.S. CEMENT RESTRICTOR DIA.24MM; MESH, SURGICAL

Catalog Number	EBO101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/02/2026
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, a removal of latitude ev total elbow replacement was performed for a patient who had an infection.The patient had a revision surgery on (b)(6) 2025.The surgeon accessed the joint and removed a significant amount of black matter and then proceeded to take the humeral and ulnar stem out.No further information was provided.
Event or Problem Description
It was reported that, a removal of latitude ev total elbow replacement was performed for a patient who had an infection.The patient had a revision surgery on (b)(6) 2025.The surgeon accessed the joint and removed a significant amount of black matter and then proceeded to take the humeral and ulnar stem out.No further information was provided.Later it was added that after speaking to the surgeon he mentioned the patient had gone well and was happy with the outcome of plating the patient's arm with another companies products.
Additional Manufacturer Narrative
Correction-date of explant (d6b) added.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence besides a photograph of the explanted devices were provided.The device inspection revealed the following.An evaluation of the provided images shows the devices to be intact, with all components account for and a complete cement mantle present.Without any medical imaging of the alleged event and no pathology provided, the event cannot be confirmed.A functional inspection was not possible as the device was not returned.A dimensional inspection was not possible since the devices were not returned.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.24MM
• Common Device Name: MESH, SURGICAL
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24733514
• Report Number: 3000931034-2026-00319
• Device Sequence Number: 9242028
• Product Code: FTM
• UDI-Device Identifier: 03700386922053
• UDI-Public: (01)03700386922053(11)250308(17)300308(21)5804BB024
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K973453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

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: 03/08/2026
• Device Catalogue Number: EBO101
• Device Lot Number: 5804BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2025
• 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: Unknown