MAUDE Adverse Event Report: ARTHREX, INC. PS TIBIAL BEARING, SIZE 2, 8MM, VIT E; KNEE PROSTHESIS PAT/FEM/TIB

Model Number	PS TIBIAL BEARING, SIZE 2, 8MM, VIT E
Medical Device Problem Codes	Positioning Failure (1158); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, it was reported by a sales representative via (b)(4) that an ar-523-b208 ps tibial bearing did not seat during implantation.This was discovered during the case.Another device was used to complete the case with no patient harm.
Additional Manufacturer Narrative
Additional information: one unpackaged ar-523-b208 ps tibial bearing batch number: 579224705 was received for investigation.Visual evaluation of the returned device noted damage to the edges of the device.Further observation noted superficial damage with nicks and scratches.Functional testing was not able to be performed due to the damage to the device.The most likely cause for the reported failure can be attributed to misuse due to use error/mishandling due to the damage to the device.The surgical technique for this device outlines the following steps for implantation of the tibial component: insert the final tibial bearing component into the tibial tray component anteriorly with the articulating surface facing the femoral component.Slide the tibial bearing component posteriorly until the posterior slot on the bearing engages the posterior lip on the tibial tray.Push the anterior edge of the tibial bearing down into the tibial tray component using thumb pressure until it snaps into place.Refer to investigation photos.Complaint allegation is confirmed.

• Brand Name: PS TIBIAL BEARING, SIZE 2, 8MM, VIT E
• Common Device Name: KNEE PROSTHESIS PAT/FEM/TIB
• 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: jared engle ; 8009337001
• MDR Report Key: 21400487
• Report Number: 1220246-2025-00471
• Device Sequence Number: 12892567
• Product Code: MBH
• UDI-Device Identifier: 00888867232242
• UDI-Public: (01)00888867232242(11)230101(17)271231(10)579224705
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K171365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PS TIBIAL BEARING, SIZE 2, 8MM, VIT E
• Device Catalogue Number: AR-523-B208
• Device Lot Number: 579224705
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown