MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah TRIATH HINGE INSERT SIZE 4 11MM; Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, co

Catalog Number	5612-P-411
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This is for the revision on (b)(6) 2025.The patient had left tka out of cors scope.The patient developed pji and was revised (all components) on (b)(6) 2025 (is then included in cors).The patient received a triathlon revision system.The patient developed again pji and is revised on (b)(6) 2025.Only the poly and rotating hinge components were 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 hinge femur 3l ; cat# 5612f301; lot# y2a6n.Device name# triathlon hinge bplate size 4; cat# 5612b400; lot# yjn9y.Device name# tri press-fit stem 14mm x 100mm; cat# 5565-s-014; lot# 0136434l.Device name# tri press-fit stem 14x150mm; cat# 5566-s-014; lot# 0137526a.Device name# triath hinge femdistaugment sz3 10mm; cat# 5612-d-310; lot# w18nkr.Device name# triath bushingsaxle stdassemblypack; cat# 5612-3-000; lot# tj4w37.Device name# triath hinge bumper 3 degrees ; cat# 5612-4-003; lot# erntv2a.Device name# tri hinge tib bearing sz 3-4 ; cat# 56120003; lot# 8674284a.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: TRIATH HINGE INSERT SIZE 4 11MM
• 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: 50419196
• Report Number: 0002249697-2026-00746
• Device Sequence Number: 10630395
• Product Code: MBH
• UDI-Device Identifier: 07613327601893
• UDI-Public: 07613327601893
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K251665
• 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-P-411
• Device Lot Number: E98LJ3
• 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: 03/29/2025
• 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 Sex: Male
• Patient Weight: 190 LB