MAUDE Adverse Event Report: TORNIER S.A.S. RADIAL PROSTHESIS CUP DIA 19 MM; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Model Number	DTJ019
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/07/2023
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.Device discarded.
Event or Problem 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 CUP DIA 19 MM
• Common Device Name: 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: 16673618
• Report Number: 3000931034-2023-00082
• Device Sequence Number: 5219645
• Product Code: KWI
• UDI-Device Identifier: 03700386901232
• UDI-Public: 03700386901232
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K994041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2023

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 Model Number: DTJ019
• Device Catalogue Number: DTJ019
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 04/04/2023
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female