MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah TRIATHLON PS X3 TIBIAL INSERT; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer

Catalog Number	5532-G-409-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: tri ts baseplate size 4; cat # 5521-b-400; lot # rzl4sb.Tri cemented stem 12mmx50mm; cat # 5560-s-112; lot # 1185542d.Triathlon p/a cr beaded #5r; cat # 5517f502; lot # rax7h.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
The following information was provided: revision due to infection.Femur, tibial insert & baseplate with stem removed, wash out, and new implants put in.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Common Device Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer
• 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: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; +353()61498200
• MDR Report Key: 25305100
• Report Number: 0002249697-2026-00463
• Device Sequence Number: 9368595
• Product Code: JWH
• UDI-Device Identifier: 07613327338355
• UDI-Public: 07613327338355
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K242831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 5532-G-409-E
• Device Lot Number: 1E50D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female