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

Catalog Number	EBO101
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 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.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 the device is returned or if any additional information is provided, the investigation 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.As no further information could be obtained, the revision surgery has been captured as it was planned.

• 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: 23649269
• Report Number: 3000931034-2025-00622
• Device Sequence Number: 4903027
• Product Code: FTM
• UDI-Device Identifier: 03700386922053
• UDI-Public: (01)03700386922053(11)420317(17)290317(21)5982BA111
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K973453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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 Catalogue Number: EBO101
• Device Lot Number: 5982BA
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2024
• 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