MAUDE Adverse Event Report: ARTHREX, INC. CR PLUS TIB BEARING, VIT E, SZ 4, 9MM; KNEE PROSTHESIS PAT/FEM/TIB

Model Number	CR PLUS TIB BEARING, VIT E, SZ 4, 9MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
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) 2024, it was reported by a sales representative via phone that an ar-523-a409 cr plus tib bearing, vit e, sz 4, 9mm would not properly seat in the tibial tray.Another of the same product from the same lot was used without issues.There was no case delay.This was discovered during a total knee arthroplasty procedure on (b)(6) 2024, with no reported patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation.

• Brand Name: CR PLUS TIB BEARING, VIT E, SZ 4, 9MM
• 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: 21020957
• Report Number: 1220246-2024-09062
• Device Sequence Number: 3969738
• Product Code: MBH
• UDI-Device Identifier: 00888867231528
• UDI-Public: (01)00888867231528(11)210201(17)260131(10)579205009
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Expiration Date: 01/31/2026
• Device Model Number: CR PLUS TIB BEARING, VIT E, SZ 4, 9MM
• Device Catalogue Number: AR-523-A409
• Device Lot Number: 579205009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• 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