MAUDE Adverse Event Report: TORNIER S.A.S. RADIAL PROSTHESIS STEM DIAM. 6.5MM; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Model Number DTJ006

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Implant Pain (4561)

Event Date 02/07/2023

Event Type  Injury  

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.Device discarded.

Event Description

It was reported that the patient had pain from the initial implantation of an elbow prosthesis 4 months prior.The surgeon analyzed that the prosthesis was overstuffed and had created pain on the humeral cartilage.Revision was performed with a mopyc head small, neck medium and stem small.Surgeon had difficultly to remove cement from bone shaft, but after this step implantation of the mopyc was easy.

• Brand Name: RADIAL PROSTHESIS STEM DIAM. 6.5MM
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• 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: 16673628
• MDR Text Key: 312604240
• Report Number: 3000931034-2023-00083
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 03700386901218
• UDI-Public: 03700386901218
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K994041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DTJ006
• Device Catalogue Number: DTJ006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female