MAUDE Adverse Event Report: ARTHREX, INC. PS TIBIAL BEARING, SIZE 4, 14MM, VIT E; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	PS TIBIAL BEARING, SIZE 4, 14MM, VIT E
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 it was reported by a arthrex employee via phone that an ar-523-b414 tibial bearing popped out of the tibial tray.This occurred after a case.Revision surgery on (b)(6) 2022, replaced with an ar-513-be16, batch number 113601819.
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.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation found that the device ar-523-b414 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: PS TIBIAL BEARING, SIZE 4, 14MM, VIT E
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: 15361901
• Report Number: 1220246-2022-05440
• Device Sequence Number: 12274270
• Product Code: MBH
• UDI-Device Identifier: 00888867232501
• UDI-Public: 00888867232501
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2022

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: 02/28/2022
• Device Model Number: PS TIBIAL BEARING, SIZE 4, 14MM, VIT E
• Device Catalogue Number: AR-523-B414
• Device Lot Number: 5791706
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 12/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2017
• 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