MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA TIB CEMENTED TRAY, SIZE 5 LM/RL; KNEE PROSTHESIS

Model Number	IBAL UKA TIB CEMENTED TRAY, SIZE 5 LM/RL
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 3/25/2024, it was reported by a sales representative via phone that an ar-511-t5l ibalance uka tibial tray and the ar-521-tbe0 ibalance uka tibial bearing implant were not engaging/locking.The case was completed using another r-521-tbe0 ibalance uka tibial bearing implant, which resulted in a 20-minute delay in the procedure without adverse effects on the patient.This was discovered during a uni-knee replacement procedure on (b)(6) 2024, with no reported patient harm.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint was not confirmed.The alleged event could not be replicated.One unpackaged ar-521-tbe0 ibalance® uka tibial bearing implant, vit e, size 5, 10 mm thickness serial/batch number (b)(6) was received for evaluation.Visual inspection found that the returned instrument's front face had nicks, gouges, and bent.Scratches and deformation of the material at the edges were also observed.Functional testing setting the tibial bearing inside the returned mating part ar-511-t5l ibalance® uka tibial tray cemented size 5 left medial right lateral, batch 11515723, found no resistance or issues.The tibial bearing fit perfectly inside the tibial tray without issues no problem found.Evaluation of the returned device included measurements of critical dimensions per drawing c12015 at revision 3.The most likely cause(s) of reported failure is user error following the surgical technique.According to ibalance® uka system surgical technique.Implantation.Tibial component determine the final thickness of the tibial bearing component by using a tibial bearing trial placed in the definitive tibial tray component.As described in the ¿trial reduction¿ section, the correct tibial bearing thickness should allow the joint space to open up 1 mm to 2 mm under varus/valgus stress (in both flexion and extension).A tibial insert trial is placed into the tibial component, the knee is reduced and brought into full extension, while the bone cement cures.Insert the tibial bearing implant after the cement has fully cured.Remove the tibial bearing trial using the tibial bearing trial puller instrument.Insert the final tibial bearing component into the tibial tray component anteriorly with the articulating surface facing the femoral component.Slide the tibial bearing component posteriorly until the posterior slot on the bearing engages the posterior lip on the tibial tray.Push the anterior edge of the tibial bearing down into the tibial tray component using thumb pressure until it snaps into place.Note: there is a 5° clearance built into the tibial bearing to allow for ease of insertion.It is normal for there to be a small gap at the anterior aspect in between the tibial bearing and the tibial tray once the bearing is fully seated.-according to dfu-0182-5 at revision 0.E.Warnings.10.Pre-operative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the device, are important considerations in the successful utilization of this device.The appropriate arthrex delivery system is required for proper implantation of the device.

• Brand Name: IBAL UKA TIB CEMENTED TRAY, SIZE 5 LM/RL
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19126754
• Report Number: 1220246-2024-02090
• Device Sequence Number: 8283742
• Product Code: HSX
• UDI-Device Identifier: 00888867334236
• UDI-Public: 00888867334236
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K200433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: IBAL UKA TIB CEMENTED TRAY, SIZE 5 LM/RL
• Device Catalogue Number: AR-511-T5L
• Device Lot Number: 11515723
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2020
• 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
• Patient Sex: Unknown