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

Model 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	06/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.When additional information becomes available, it will be provided on a supplemental report.Device disposition unknown.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to an infection 12 months post-op.The metal devices were removed and a competitor's cement spacer was inserted.
Additional Manufacturer Narrative
The reported event could not be confirmed since the involved devices were 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.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to an infection 12 months post-op.The metal devices were removed and a competitor's cement spacer was inserted.

• Brand Name: CEMENT RESTRICTOR DIAM.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: 15044272
• Report Number: 3000931034-2022-00258
• Device Sequence Number: 6919734
• 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: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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: 10/26/2025
• Device Model Number: EBO101
• Device Catalogue Number: EBO101
• Device Lot Number: 0923AW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2020
• 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; Hospitalization
• Patient Sex: Unknown