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	Pain (1994)
Date of Event	08/10/2020
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 by a medical professional that a patient underwent a total knee procedure (b)(6) 2018.The patient later underwent a revision tka procedure sometime in (b)(6) 2020.Additional information obtained 10/27/2020: an arthrex sales rep has obtained and provided the following additional information: patient had reported to a different surgeon as having pain on the operative side.The second surgeon performed a revision tka, (b)(6) 2020 and revised the tibial component.The femur was found to be well fixated at the time of revision.The following original implant devices were explanted at the time of revision: ar-513-t5, ibalance tka tibial tray, lot 10183321, ar-523-b510, ibalance tka tibial bearing implant (size 5), lot 5791643.The following original implant devices were left in the patient at the time of revision: ar-516-6l, ibalance tka femoral implant, lot 10053281, ar-524-psc9, ibalance patella implant, lot 132581743.The following devices were implanted at the time of revision: ar-513-t4, ibalance tka modular tibial tray, lot 10572760, ar-513-be-16, ibalance tka bearing implant (size 4), lot 113601819, ar-513-1050.Ibalance tka tibial stem, lot 10018103.

• 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: 10842940
• Report Number: 1220246-2020-02335
• Device Sequence Number: 17051295
• Product Code: MBH
• UDI-Device Identifier: 00888867187887
• UDI-Public: 00888867187887
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2020

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 Model Number: IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 5
• Device Catalogue Number: AR-513-T5
• Device Lot Number: 10183321
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/16/2020
• 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
• Patient Age: 57 YR