MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA FEM CEMENTED SIZ 3,L-MEDIAL; KNEE PROSTHESIS

Model Number	IBAL UKA FEM CEMENTED SIZ 3,L-MEDIAL
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, it was reported by through a patient's legal filing that on (b)(6) 2017 the patient underwent a left knee uni-compartmental knee arthroplasty.During the procedure the surgeon implanted an arthrex ibalance uni-compartmental knee system with a size 3 femoral component, size 4 tibial tray, and an 8 mm tibial bearing insert into the left knee medial parapatellar facetectomy.Thereafter the patient was having pain in the left knee and on (b)(6) 2019 and mri of the knee was taken which revealed ¿metallic artifact is present involving the medial compartment obscuring and distorting the underlying and adjacent structures.¿ on (b)(6) 2019 the patient reported a crunching sensation on the medial aspect of the knee.On (b)(6) 2019 and again on (b)(6) 2020 the patient complained of aches, pains and weakness in the knee.On (b)(6) 2020 the patient presented to another surgeon and a bone scan was ordered which revealed a loose implant.The patient was referred to another surgeon to discuss revision options due to loosening of the implant and on (b)(6), 2020 that surgeon performed an explantation and antibiotic spacer placement, left total knee arthroplasty and saucerization of femoral tibial bone for infection.It is unknown what manufacturers devices were used for the revision total knee arthroplasty.The patient continued to report issues and a second total knee revision arthroplasty was performed on (b)(6), 2020.It is unknown what devices were explanted and what manufacturers devices were used in the second revision surgery.No further information has been provided to date.
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
Additional information: g3, 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.

• Brand Name: IBAL UKA FEM CEMENTED SIZ 3,L-MEDIAL
• 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: emily shafer ; 8009337001
• MDR Report Key: 17980983
• Report Number: 1220246-2023-08293
• Device Sequence Number: 17011912
• Product Code: KRR
• UDI-Device Identifier: 00888867034266
• UDI-Public: 00888867034266
• 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
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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: 06/30/2022
• Device Model Number: IBAL UKA FEM CEMENTED SIZ 3,L-MEDIAL
• Device Catalogue Number: AR-501-UFLC
• Device Lot Number: 10151498
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2017
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown