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

Catalog Number	DTJ006
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Subluxation (4525); Joint Laxity (4526)
Date of Event	10/04/2022
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: "dislocation of the elbow (in the event of major instability) prosthesis placement on (b)(6) 2022, subluxation noted on the visit of (b)(6) 2022, prosthesis change on (b)(6) 2022.To address this matter comprehensively, a corrective re-operation was conducted.This involved the extraction of the existing implant and the subsequent re-implantation of a new prosthesis.".

• Brand Name: BI POLAR RADIAL STEM 6.5 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: 19366919
• Report Number: 3000931034-2024-00312
• Device Sequence Number: 6500423
• Product Code: KWI
• 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: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 05/21/2024
• 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: 25 YR
• Patient Sex: Male
• Patient Weight: 68 KG