MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON HINGE INSERT SIZE 5 13MM; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Catalog Number	5612-P-513
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: it was reported that the patient's right knee was revised due to infection.A triathlon hinge insert, tibial bearing component, bumper, bushings, and axle were exchanged.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
The following devices were also listed in this report: tri hinge tib bearing sz 5-6; cat # 56120005; lot # g8704954.Triathlon bushingsaxle stdassemblypack; cat # 5612-3-000; lot # wl1xd0.Triathlon hinge bumper neutral; cat # 5612-4-000; lot # errmh7a1.Triathlon cemented stem-15mm x 50mm; cat # 5560-s-115; lot # 1214654e.Tri cemented stem 12mmx50mm; cat # 5560-s-112; lot # 1198726j.Tritanium patella-asymmetric; cat # 5552-l-350; lot # 1x801.Triathlon sym cone aug sz c; cat # 5549-a-130; lot # 2xkv1.Triathlonctrfemconeaug sz3&4r; cat # 5549-a-642; lot # x30k1.Triathlon hinge b/plate size 5; cat # 5612b500; lot # t434p.Triathlon hinge femur 5r; cat # 5612f502; lot # ysx3r.Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There has been similar event(s) for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

• Brand Name: TRIATHLON HINGE INSERT SIZE 5 13MM
• Common Device Name: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 24979805
• Report Number: 0002249697-2026-00333
• Device Sequence Number: 21445404
• Product Code: KRO
• UDI-Device Identifier: 07613327601961
• UDI-Public: 07613327601961
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K251665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2026

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-513
• Device Lot Number: P13V45
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• 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: 55 YR
• Patient Sex: Male