MAUDE Adverse Event Report: TORNIER S.A.S. CEMENT RESTRICTOR DIA.24MM; CEMENT OBTURATOR

Catalog Number	EBO101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
Date of Event	09/30/2025
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 underwent left total elbow replacement (for post-traumatic arthritis) at (b)(6) hospital, on (b)(6) 2023.Surgeon unknown.He has been experiencing pain, swelling, poor range of movement for many months, referred to (b)(6) hospital.During surgery, a decision made by surgeon to remove all implants, as the joint was obviously infected.All primary implants removed, without too much difficulty, and an antibiotic spacer inserted.Stage 2 of the revision to be attended to in the future, when clinical markers of infection are not evident.No further information was available.
Additional Manufacturer Narrative
The reported event could be confirmed, since.X-rays of the event were provided by the reporter along with pathology to confirm the presence of an infection.The device inspection revealed the following the provided images of the case were evaluated by a stryker hcp which revealed the following all of the components of the implant are intact and properly placed.However, in the x-ray a radiolucent line around the cement mantle of the ulnar component is present, in addition to a positive culture provided by the reporter verifies an infection is present.A functional and dimensional inspection was not possible since the device was not returned.However, during manufacturing, functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications.Considering the low probability of device-related infections occurring at this stage, coupled with the understanding of the typical timeline and nature of late-onset infections associated with implant materials, it has been determined that completing the infection checklist for implants within this timeframe is unnecessary.Due to the age of the device being implanted in 2023, an evaluation of the provided x-rays and pathology by a stryker hcp, the root cause was attributed to a patient related issue.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 underwent left total elbow replacement (for post-traumatic arthritis) at cairns base hospital, on (b)(6) 2023.Surgeon unknown.He has been experiencing pain, swelling, poor range of movement for many months, referred to princess alexandra hospital.During surgery, a decision made by surgeon to remove all implants, as the joint was obviously infected.All primary implants removed, without too much difficulty, and an antibiotic spacer inserted.Stage 2 of the revision to be attended to in the future, when clinical markers of infection are not evident.No further information was available.

• Brand Name: CEMENT RESTRICTOR DIA.24MM
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23430895
• Report Number: 3000931034-2025-00588
• Device Sequence Number: 8178705
• Product Code: LZN
• UDI-Device Identifier: 03700386922053
• UDI-Public: (01)03700386922053(11)220825(17)270825(21)2613AY144
• 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 Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 2613AY
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2022
• 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 Age: 66 YR
• Patient Sex: Male