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); Synovitis (2094)
Date of Event	03/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to arthrex's follow-up requests.The device was not returned for evaluation and the contribution of the device to the reported event could not be determined.The information received regarding the event is not sufficient to determine the cause of the event.
Event or Problem Description
It was reported by the patient's legal representative that the patient underwent a right total knee arthroplasty procedure on (b)(6) 2014.The following arthrex products were implanted during the primary procedure; ar-516-7r (lot: 108761331), ar-503-tttf (lot: 108761203), ar-504-psc9 / (lot: 113601324), ar-503-bf09 / (lot: 113601236).It was reported that the tibial baseplate was extremely loose and that the patient has substantial synovitis that required a complete synovectomy along with a revision total knee arthroplasty.The patient underwent a right total knee revision surgery on (b)(6) 2019.The revision procedure took place at the same facility as the primary, and was performed by the same surgeon.Ar-503-tttf (lot: 108761203) was explanted during the revision surgery.The revision was completed using another manufacturer's devices.

• 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
• MDR Report Key: 11552786
• Report Number: 1220246-2021-02776
• Device Sequence Number: 3844135
• Product Code: JWH
• UDI-Device Identifier: 00888867106734
• UDI-Public: 00888867106734
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K081127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2021

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: 108761203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/23/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR