MAUDE Adverse Event Report: TORNIER S.A.S. BI POLAR RADIAL CUP 22MM DIA; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Catalog Number	DTJ022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Implant Pain (4561)
Date of Event	09/15/2023
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 in a supplemental report.
Event or Problem Description
As reported: "welbow study subject (b)(6): one month after the surgery involving the crf ii implant, heterotopic ossification with neuropathic pain was observed.It was observed a neuropathic pain starting from the elbow and radiating through the right upper limb.To address this issue rehabilitation and physical therapy were required.".

• Brand Name: BI POLAR RADIAL CUP 22MM DIA
• 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: 20451843
• Report Number: 3000931034-2024-00619
• Device Sequence Number: 7044766
• Product Code: KWI
• UDI-Device Identifier: 03700386901249
• UDI-Public: 03700386901249
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• 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: DTJ022
• 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: 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: 49 YR
• Patient Sex: Male
• Patient Weight: 69 KG