MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 5
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported the a patient had undergone a tka procedure (b)(6) 2019.During the 2019 procedure the following arthrex products were implanted: ar-513-t5, ibalance tka modular tibial tray (lot 10280798), ar-513-bf18, ibalance tka bearing implant (lot 113601824), ar-516-6l, ibalance femoral implant (lot 10221540), ar-524-psd0, patella implant dome (lot 132581832).Roughly 6 months post op the patient began having issues with fully extending the knee.It was reported there was a post-op disengagement of the poly from the tray.The patient underwent a revision surgery at the same facility by the same surgeon.During the revision all of the original arthrex devices were explanted.To complete the revision procedure another manufacturer's product was used.Risk management department at the facility has possession of the explanted devices.Additional information provided 11/23/20: the revision procedure took place (b)(6) 2020.

• Brand Name: IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 5
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10962335
• Report Number: 1220246-2020-02400
• Device Sequence Number: 11836167
• Product Code: MBH
• UDI-Device Identifier: 00888867187887
• UDI-Public: 00888867187887
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2020

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: 01/31/2024
• Device Model Number: IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 5
• Device Catalogue Number: AR-513-T5
• Device Lot Number: 10280798
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other