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

Catalog Number	EBO102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Implant Pain (4561)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device disposition unknown.
Event or Problem Description
The subject reported heightened pain during maximum flexion, alongside slightly elevated inflammatory markers.A ct scan revealed indications of infection around the tip of the ulnar prosthesis.Following clinical feedback, a spect ct scan has been ordered to define required actions.The surgeon suggested that the infection is not directly linked to the implant but has a casual relationship with the initial surgery.
Additional Manufacturer Narrative
The reported event was not confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.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.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
The subject reported heightened pain during maximum flexion, alongside slightly elevated inflammatory markers.A ct scan revealed indications of infection around the tip of the ulnar prosthesis.Following clinical feedback, a spect ct scan has been ordered to define required actions.The surgeon suggested that the infection is not directly linked to the implant but has a casual relationship with the initial surgery.

• 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: 18449987
• Report Number: 3000931034-2024-00003
• Device Sequence Number: 7566870
• Product Code: LZN
• UDI-Device Identifier: 03700386928710
• UDI-Public: 03700386928710
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K061824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2024

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Age: 55 YR
• Patient Sex: Unknown
• Patient Weight: 116 KG