MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA,BEARING IMP,PS,SZ 2,16MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	IBAL TKA,BEARING IMP,PS,SZ 2,16MM
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/28/2022
Type of Reportable Event	Malfunction
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
On 10/28/2022, it was reported by an arthrex employee via email that a patient underwent revision surgery due to an ar-513-bc16 tka tibial bearing disassociating from the tibial tray.No further information has been given at time.Additional information received on 11/3/2022: due to osteoarthritic knee, patient had a tka procedure on (b)(6) 2018.An ar-516-5l femoral implant, an ar-524-psbb8 patella implant dome, an ar-513-t2 tibial tray, an ar-523-b214 tibial bearing, and an ar-513-bc16 tibial bearing were implanted.When the tibial bearing and the tibial tray disassociated from one another, a poly exchange procedure was performed on (b)(6) 2022.During the procedure, an ar-513-bc16 tibial bearing, lot number 113601350, was removed and an ar-513-bc16 tibial bearing, lot number 113601816 was implanted.Case was completed successfully without further issues.Both surgeries took place in the same facility and performed by the same surgeon.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation found that the device ar-523-bc16 has the locking mechanism damaged and posterior locking tabs broken.The peg and the anterior side of the device is deformed with signs of wear, and surface cuts from assembling and removing the device from the tibial tray.The probable cause of these damage can be for the excessive flexion of the knee, causing the device popped out.The cause remains undetermined.

• Brand Name: IBAL TKA,BEARING IMP,PS,SZ 2,16MM
• 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: 15804010
• Report Number: 1220246-2022-05764
• Device Sequence Number: 5501308
• Product Code: JWH
• UDI-Device Identifier: 00888867107106
• UDI-Public: 00888867107106
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K133342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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 Expiration Date: 01/31/2019
• Device Model Number: IBAL TKA,BEARING IMP,PS,SZ 2,16MM
• Device Catalogue Number: AR-513-BC16
• Device Lot Number: 113601350
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2014
• 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