MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA FEM IMP PS,CEMENTED SZ 7 RGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	IBAL TKA FEM IMP PS,CEMENTED SZ 7 RGHT
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/01/2014
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported by the patient¿s legal representative that the patient underwent a right total knee procedure on (b)(6) 2014, and is experiencing unknown issues with the knee replacement.The following arthrex product was implanted during the primary procedure: ar-503-ttth (lot: 780842), ar-516-7r (lot: 108761412) x 2, ar-513-bh10 (lot: 113601339), ar-504-psd0 (lot: 113601323).To date no revision has been reported.The patient also had a left total knee procedure on (b)(6) 2014 which was revised on (b)(6) 2019 (see case (b)(4)).Additional information received on 4/26/2021: arthrex has received confirmation that the patient's right knee was revised on (b)(6) 2021.No additional details pertaining to the revision surgery have been provided.

• Brand Name: IBAL TKA FEM IMP PS,CEMENTED SZ 7 RGHT
• 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: 11841746
• Report Number: 1220246-2021-03102
• Device Sequence Number: 3747714
• Product Code: JWH
• UDI-Device Identifier: 00888867109391
• UDI-Public: 00888867109391
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/18/2021

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: IBAL TKA FEM IMP PS,CEMENTED SZ 7 RGHT
• Device Catalogue Number: AR-516-7R
• Device Lot Number: 108761412
• 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: 05/18/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other