MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA FEM, PS CEMENTED, SZ 4, RIGHT; PROSTHESIS, SHOULDER, CEMENTED

Model Number	IBAL TKA FEM, PS CEMENTED, SZ 4, RIGHT
Medical Device Problem Codes	Degraded (1153); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, it was reported by a patient that an arthrex knee implant had been placed approximately four years prior.The patient experienced persistent pain and frequent falls throughout that time.It was later determined that the implant had fallen apart, resulting in fractures to the bones in the knee.A total revision and bone graft procedure was performed in late (b)(6) 2025.Additional information received on 10/9/2025: the patient underwent right knee surgery on (b)(6) 2021, during which arthrex implants were used.A revision procedure was later performed on (b)(6) 2025.Throughout the course of treatment, the patient received multiple evaluations, including x-rays and mris, as well as physical therapy.Additional orthopedic consultations were conducted on (b)(6) 2024 to assess the condition of the right knee implant.Nothing further was provided.Additional information was received on 10/14/2025: part number ar-513-t2 inbalance tka modular tibial tray and an ar-526-4r ibal tka fem, ps cemented were both implanted and later explanted.
Event or Problem Description
Additional information was received on 10/14/2025: per the patient's medical records, the patient reported persistent pain rated between 7/10 and 9/10, stiffness, and limited range of motion from the time of implantation.The patient was unable to return to the previous level of activity and relied on a cane for mobility.Frequent falls and functional decline were noted, including difficulty with daily tasks such as shopping and exercising.Imaging and ct scans performed in 2024 showed no gross malpositioning, but mild tibial rotation was noted.Despite these findings, the patient continued to experience debilitating symptoms.A surgical pathology report dated (b)(6) 2025, confirmed mechanical loosening of the implant and degenerative changes in the surrounding bone and synovial tissue.Physical therapy records post-revision documented improved gait, reduced swelling, and progress toward functional goals, including stair climbing and sit-to-stand exercises.Pain levels decreased to an average of 2¿5/10, with continued monitoring and rehabilitation.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is not confirmed.Photographic evidence submitted from the field shows only surface damage to the ar-526-4r, ibal tka femoral component, ps cemented, size 4, right.The batch number was not provided.Based on the available information and visual confirmation, arthrex has determined that the most likely cause is a patient-specific event.Based on the submitted images, the implant appears to be well-cemented, structurally intact, and free from any visible damage or breakage.Given the patient's history of persistent pain and frequent falls over a four-year period following implantation, the most likely cause of the issue is attributed to a patient-specific event.It is probable that cumulative trauma over time led to implant loosening, rather than a product-related failure.Per dfu-0184-4 rev.0, patients must receive detailed instructions regarding the use and limitations of this device.Patient-specific factors¿including activity level, bone quality, and adherence to postoperative protocols¿can significantly influence outcomes.Engaging in activities that place excessive stress on implants (e.G., running, lifting, skiing) may lead to premature implant failure.It is critical that the fixation provided by the device be protected until healing is complete, and that the postoperative regimen prescribed by the physician be strictly followed to minimize the risk of adverse stresses on the implant.Section e.Warnings: postoperatively and until healing is complete, the fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid applying adverse stresses to the device.Section d.Adverse effects: loosening, migration, or loss of fixation of the implant.Foreign body reactions.Infections, both deep and superficial.Particulate wear debris and mild tissue discoloration from metallic components have been noted with other prosthetic devices constructed of similar materials.Some types of wear debris have been associated with osteolysis and implant loosening.Wear and damage to the articulating surfaces or soft tissue support structures.Postoperative symptoms may include, but are not limited to: pain, persistent swelling, stiffness, limited range of motion, or incomplete resolution of preoperative symptoms.Conclusion: the implant was evaluated onsite, and based on the assessment, it was determined that the most likely cause of the issue is a patient-specific event.This conclusion aligns with the patient¿s history of persistent pain and frequent falls over a four-year period following implantation and concurs with the current investigation findings.

• Brand Name: IBAL TKA FEM, PS CEMENTED, SZ 4, RIGHT
• Common Device Name: PROSTHESIS, SHOULDER, CEMENTED
• 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: 23335635
• Report Number: 1220246-2025-04691
• Device Sequence Number: 9937559
• Product Code: JWH
• UDI-Device Identifier: 00888867300330
• UDI-Public: 00888867300330
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: IBAL TKA FEM, PS CEMENTED, SZ 4, RIGHT
• Device Catalogue Number: AR-526-4R
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 10/14/2025; 12/19/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/12/2025; 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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