MAUDE Adverse Event Report: TORNIER S.A.S. CEMENT RESTRICTOR DIA.13MM; CEMENT OBTURATOR

Catalog Number	EBO102
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received a report from the national joint registry that contains unpublished collected data on the usage and the outcomes with the tornier elbow system.The report details analysis provided for procedures performed between june 2018 ¿ july 2023.During the review of the report, it was identified that on (b)(6) 2018 a patient required revision surgery due to aseptic loosening, which was not previously reported to the manufacturer.
Additional Manufacturer Narrative
The reported event that one patient required revision surgery due to aseptic loosening could not be confirmed, since the device was not returned for evaluation and no other additional information was received from the national joint registry.More detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.Please note, that reports received from the national joint registry are not published reports and therefore web link is not available.

• Brand Name: CEMENT RESTRICTOR DIA.13MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20449255
• Report Number: 3000931034-2024-00617
• Device Sequence Number: 7082152
• Product Code: LZN
• UDI-Device Identifier: 03700386928710
• UDI-Public: 03700386928710
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K061824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/15/2024

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: EBO102
• Device Lot Number: 6800AT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 63 YR
• Patient Sex: Female