MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA TIBIAL TRAY SIZE 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	IBALANCE TKA TIBIAL TRAY SIZE 5
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Swelling/ Edema (4577)
Date of Event	06/11/2013
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a patients legal representative by mail, received on 9/6/2022, that the patient underwent a left total knee replacement on (b)(6) 2013.The surgery was performed utilizing arthrex¿s ibalance tibial tray ar-503-tttf, lot 108761150.Thereafter, the patient began to experience pain, swelling and discomfort in his left knee.On (b)(6) 2020, he presented to a different surgeon for evaluation.During this visit the surgeon informed the patient of the possibility of premature mechanical loosening of the ibalance knee prosthesis and revision surgery was recommended.On (b)(6) 2021, the patient underwent a revision procedure at (b)(6).According to the patient, the surgeon noted that the tibial component was grossly loose during the revision and that his tibial tray device was subject to a recall.According to the part/lot numbers identified in the photographs the patient¿s legal representative provided, the specific tibial tray is not subject to a recall.
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
Complaint is not confirmed one unpackaged ar-503-tttf ibalance tka tibial tray implant serial/batch number 108761150 was received for investigation.Visual evaluation did not find issues with the device.Additionally, the device history record investigation found that this batch was not affected by the recall.Functional test with ar-503-be12, batch# 77941243, found that the template fit without any issues in the received ibalance tka tibial tray implant, size 5.

• Brand Name: IBALANCE TKA TIBIAL TRAY SIZE 5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 15493468
• Report Number: 1220246-2022-05549
• Device Sequence Number: 1918637
• Product Code: JWH
• UDI-Device Identifier: 00888867106734
• UDI-Public: 00888867106734
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K081227
• 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): 02/03/2023

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 Model Number: IBALANCE TKA TIBIAL TRAY SIZE 5
• Device Catalogue Number: AR-503-TTTF
• Device Lot Number: 108761150
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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