MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah NO 3 TRIATH TS PLUS TIB INS X3 POLY 9MM; Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, co

Catalog Number	5537-G-309-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had an index right tka on (b)(6) 2025.The patient developed pji, and was revised on (b)(6) 2025.Only poly was exchanged.
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# triathlon ps fem component cemented; cat# 5515-f-302; lot# sth4ba device name# tri ts baseplate size 3; cat# 5521-b-300; lot# hox9va device name# triath symmetric x3 patella; cat# 5550-g-339-e; lot# 8w9p device name# tri cmnt stem 12mmx50mm; cat# 5560-s-112; lot# 1669916d.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: NO 3 TRIATH TS PLUS TIB INS X3 POLY 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: 50419194
• Report Number: 0002249697-2026-00745
• Device Sequence Number: 21490343
• Product Code: MBH
• UDI-Device Identifier: 07613327287981
• UDI-Public: 07613327287981
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Study
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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: 5537-G-309-E
• Device Lot Number: WP89J2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2023
• 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 Age: 85 YR
• Patient Sex: Male
• Patient Weight: 145 LB