MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA TIB TRAY SZ 4,RT-MEDIAL; PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	IBAL UKA TIB TRAY SZ 4,RT-MEDIAL
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 7/25/2022, it was reported through a patient's legal filing that on (b)(6) 2018 the patient underwent a right knee medial uni-compartmental knee arthroplasty using the following arthrex ibalance uni-compartmental knee system devices: ibalance uka tibial bearing implant, size 4 ar-521-tbd8 (lot 5791631), ibalance uka femoral size 3 ar-501-ufrc (lot 10144742) and ibalance uka tibial tray size 4 ar-501-ttrd (lot 10223657) thereafter on (b)(6) 2019 the patient complained of aches and pains in the knee and during the visit the surgeon discussed a potential revision.The patient again reported aches and pains on (b)(6) 2020.On (b)(6) 2020 the patient presented to a different surgeon with complaints of pain and tenderness and an aspiration of the right knee was performed and revealed limited range of motion.The surgeon then recommended a revision procedure due to loosening.On (b)(6) 2021 the surgeon performed a right revision total knee arthroplasty, both components.It is unknown what manufacturers devices were utilized to complete the revision procedure.No further details have been given.
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
The complaint cannot be confirmed based on the customer provided photo, which does not display the failed implant.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: IBAL UKA TIB TRAY SZ 4,RT-MEDIAL
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: vik bajnath ; 8009337001
• MDR Report Key: 15226466
• Report Number: 1220246-2022-05381
• Device Sequence Number: 20234717
• Product Code: KRR
• UDI-Device Identifier: 00888867034211
• UDI-Public: 00888867034211
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022

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: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: IBAL UKA TIB TRAY SZ 4,RT-MEDIAL
• Device Catalogue Number: AR-501-TTRD
• Device Lot Number: 10223657
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 10/26/2022
• Date Device Manufactured: 07/12/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown