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 Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject: (b)(6) (welbow clinical study) few days after the surgery involving the crf ii implant, a dislocation of the elbow (in the event of major instability) was observed.It was observed a avulsion of the reattachment anchor of the lateral ligamentous plan resulted in posterior dislocation of the radial head.This event was reported as a serious adverse event ¿required intervention to prevent life-threatening illness or injury, or permanent impairment or damage to address this issue, three interventions were required : on 27 jun 2022 : re-operation without implant change : ligament reconstruction using half of the flexor carpi radialis tendon.This event corresponds to 20243724469 and 20243724470.On 12 jul 2022 : re-operation without implant change : ligament reconstruction using the controlateral palmaris longus tendon (because of recurrence of posterolateral radial dislocation after the first ligament).This event corresponds to 20243733255 and 20243733256.On 13 jul 2022 : re-operation without implant change : ligament reconstruction (because of persistence of the posterolateral radial head dislocation) this event was resolved without sequelae after last intervention.This record covers this event above.
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.

• 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: 20200593
• Report Number: 3000931034-2024-00548
• Device Sequence Number: 17846398
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/12/2024

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: 08/19/2024
• Initial Report FDA Received Date: 09/12/2024
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 67 KG