MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah X3 TRIATHLON CS INSERT 7 9MM; Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, co

Catalog Number	5531-G-709-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right knee was revised due to infection.A cr/ cs knee was removed and a ts knee with stems and augment was implanted.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.The following devices were also listed in this report: device name# tritanium patella-asymmetric; cat# 5552-l-350; lot# xlpk1 device name# triathlon p/a cr beaded 7r; cat# 5517f702; lot# 49d2b device name# tritanium bplate triathlon s7; cat# 5536b700; lot# ctd140225 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: X3 TRIATHLON CS INSERT 7 9MM
• Common Device Name: Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, co
• Manufacturer (Section D): Stryker Orthopaedics-Mahwah; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): Stryker Orthopaedics-Mahwah; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50499707
• Report Number: 0002249697-2026-00788
• Device Sequence Number: 10087964
• Product Code: MBH
• UDI-Device Identifier: 07613327337464
• UDI-Public: 07613327337464
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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 Catalogue Number: 5531-G-709-E
• Device Lot Number: 6W4A6J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male