MAUDE Adverse Event Report: TORNIER S.A.S. BI POLAR RADIAL STEM 6.5 DIA; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Catalog Number	DTJ006
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	08/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "following the surgical intervention for the radial head crf ii implant, the patient experienced postoperative complications, including elbow stiffness and implant mispositioning.According to the surgeon, this event has a causal relationship with the surgery procedure but is not related to the implant.To address this matter comprehensively, a corrective re-operation was conducted on (b)(6) 2020.This involved the extraction of the existing implant and the subsequent re-implantation of a new prosthesis.The procedure successfully rectified the complications, and the patient's condition was resolved without sequelae.".
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.H3 other text : device disposition unknown.

• Brand Name: BI POLAR RADIAL STEM 6.5 DIA
• Common Device Name: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
• 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: 19039996
• Report Number: 3000931034-2024-00192
• Device Sequence Number: 8565188
• Product Code: JDB
• UDI-Device Identifier: 03700386901218
• UDI-Public: 03700386901218
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2024

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: DTJ006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 04/04/2024
• 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: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 67 KG