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 Codes	Loss of Range of Motion (2032); Discomfort (2330); Implant Pain (4561); Insufficient Information (4580)
Date of Event	04/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient underwent a revision surgery after a suspected infection.The culture came back negative for infection.
Additional Manufacturer Narrative
Correction: h6 clinical.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.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 a revision surgery due to discomfort and stiffness and reduced range of motion.All prosthesis removed and discarded.Specimens taken for pathology.All original bone cement removed.Copious lavage attended.All joint and medullary canal surfaces irrigated with aqueous betadine.Full set of prosthesis cemented in, with antibiotic cement.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19502417
• Report Number: 3000931034-2024-00336
• Device Sequence Number: 15447098
• Product Code: FTM
• UDI-Device Identifier: 03700386922053
• UDI-Public: 03700386922053
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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 Catalogue Number: EBO101
• Device Lot Number: 3358AY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2022
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 80 KG