MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA,BEARING IMP,PS,SZ 6,13MM; KNEE PROSTHESIS PAT/FEM/TIB

Model Number	IBAL TKA,BEARING IMP,PS,SZ 6,13MM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 5/13/2025, a sales representative reported via email that a patient who underwent an ibalance procedure has experienced loose implants post-surgery.During the initial surgery, an ar-516-4r ibalance cemented tka femoral implant ps, an ar-503-tttg ibalance cemented tka tibial tray implant, an ar-504-psc9 ibalance dometka patella implant, and an ar-513-bg13 ibalance ps tka tibial bearing implant were used.Additional information was received on 5/21/2025: the original surgery took place on (b)(6) 2015 and the patient loose implants were noticed around (b)(6) 2025.Additional information received on 5/22/2025: a revision surgery has not occurred.The patient is doing well; however, wants the issue resolved.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.Per dfu-0184-4: "c.Contraindications insufficient quantity or quality of bone.Blood supply limitations and previous infections, which may retard healing.Foreign body sensitivity.Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.Any active infection or blood supply limitations.The use of this device may not be suitable for patients with insufficient or immature bone.The physician should carefully assess bone quality before performing orthopedic surgery on patients who are skeletally immature.The use of this medical device and the placement of hardware or implants must not bridge, disturb or disrupt the growth plate.Conditions that tend to limit the patient¿s ability or willingness to restrict activities or follow directions during the healing period.Do not use for surgeries other than those indicated.An overweight or obese patient can produce loads on the prosthesis which can lead to failure of fixation or failure of the device itself.Severe deformity and/or recurrent subluxation of the knee joint.Ligamentous instability or soft-tissue laxity such that the postoperative stability afforded by the prosthesis may be compromised or dislocated.

• Brand Name: IBAL TKA,BEARING IMP,PS,SZ 6,13MM
• Common Device Name: KNEE PROSTHESIS PAT/FEM/TIB
• 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: 22161038
• Report Number: 1220246-2025-02411
• Device Sequence Number: 15324565
• Product Code: HSX
• UDI-Device Identifier: 00888867107489
• UDI-Public: (01)00888867107489(11)140812(17)190228(10)113601335
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K171365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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: 02/28/2019
• Device Model Number: IBAL TKA,BEARING IMP,PS,SZ 6,13MM
• Device Catalogue Number: AR-513-BG13
• Device Lot Number: 113601335
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown