MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA FEM CEMENTED SIZ 3,R-MEDIAL; PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number IBAL UKA FEM CEMENTED SIZ 3,R-MEDIAL

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032)

Event Date 01/05/2021

Event Type  malfunction  

Event 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.

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.

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 FEM CEMENTED SIZ 3,R-MEDIAL
• Type of Device: 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: 15226418
• MDR Text Key: 297906235
• Report Number: 1220246-2022-05380
• Device Sequence Number: 1
• Product Code: KRR
• UDI-Device Identifier: 00888867034327
• UDI-Public: 00888867034327
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2022
• Device Model Number: IBAL UKA FEM CEMENTED SIZ 3,R-MEDIAL
• Device Catalogue Number: AR-501-UFRC
• Device Lot Number: 10144742
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other