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 Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Implant Pain (4561); Insufficient Information (4580)
Date of Event	03/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "welbow study subject : (b)(6).During the surgery involving the crf ii implant, an intra-operative complication was observed.The patient experienced a defect in the radial bone cut.This event was reported as a serious adverse event that required intervention to prevent life-threatening illness or injury, or permanent impairment or damage.In medical observation: indication to repeat the cut of at least 3mm, cementation of a new stem, reinsertion of the external collateral plane, procedure: change of left radial head prosthesis, 3mm cut, reinsertion of external collateral plane.Stryker reference # (b)(4) is covering this intra-op complication.Management in the operating room on (b)(6) 2024 for arthroplasty of the radial head and reinsertion of the lateral plane on anchor.Post-operative follow-up radiographs showed too much prosthetic crowding.Need for revision surgery to cut the neck of the radius and reimplant a new prosthesis.A new crf ii implant was used.This record is covering this revision surgery.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Please note correction to h6 (device code and clinical code).The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.It did reveal that intra-operatively, frequent radioscopic checks allow the position of the prosthesis to be checked.In the event description it¿s mention that the post-operative follow-up radiographs showed too much prosthetic crowding.Based on investigation, the root cause was attributed to a user related issue.The event was caused by an insufficient resection of the radius.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "welbow study subject : (b)(6).During the surgery involving the crf ii implant, an intra-operative complication was observed.The patient experienced a defect in the radial bone cut.This event was reported as a serious adverse event that required intervention to prevent life-threatening illness or injury, or permanent impairment or damage.In medical observation: indication to repeat the cut of at least 3mm, cementation of a new stem, reinsertion of the external collateral plane, procedure: change of left radial head prosthesis, 3mm cut, reinsertion of external collateral plane.Stryker reference # (b)(4) is covering this intra-op complication.Management in the operating room on (b)(6) 2024 for arthroplasty of the radial head and reinsertion of the lateral plane on anchor.Post-operative follow-up radiographs showed too much prosthetic crowding.Need for revision surgery to cut the neck of the radius and reimplant a new prosthesis.A new crf ii implant was used.This record is covering this revision surgery.".

• 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: 20462823
• Report Number: 3000931034-2024-00624
• Device Sequence Number: 18356766
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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: 7994AZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2023
• 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: 45 YR
• Patient Sex: Male