MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah TRIATH REVISION INSERT X3 SZ4 9MM; Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, co

Catalog Number	5612-X-409
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a history of trauma on right knee treated non-surgically.Patient had an index right tka on (b)(6) 2025 treated with short stems in femur and tibia.The patient had a trauma and presented with a patellar fracture on an unresurfaced patella with lateralization of the patella, managed non-surgically.Later patient developed pji, and was revised on (b)(6) 2025.Only poly was exchanged and the patella was resurfaced.
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# tri ts femur sz5 right; cat# 5512-f-502; lot# rvd7t.Device name# triathlon hinge bplate size 4; cat# 5612b400; lot# tx36n.Device name# tri cmnt stem 12mmx50mm; cat# 5560-s-112; lot# 1185527k.Device name# triath cmnt stem-9mm x 50mm; cat# 5560-s-109; lot# 1191457h.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: TRIATH REVISION INSERT X3 SZ4 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: 50422456
• Report Number: 0002249697-2026-00754
• Device Sequence Number: 10370535
• Product Code: MBH
• UDI-Device Identifier: 07613327560015
• UDI-Public: 07613327560015
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K230416
• 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: 5612-X-409
• Device Lot Number: K38464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 180 LB