MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah TRIATH HINGE INSERT SIZE 6 11MM; prosthesis, knee, femorotibial, constrained, cemented, metal/polymer

Catalog Number	5612-P-611
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had right tka out of cors scope.The patient developed pji and was revised (all components) on (b)(6) 2024 (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
The following devices were also listed in this report: triath bushingsaxle stdassemblypack; cat # 5612-3-000; lot # lp4mk5 triath hinge bumper 3 degrees; cat # 5612-4-003; lot # ernsh2d tri hinge tib bearing sz 5-6; cat # 56120005; lot # g868087a triathlon hinge femur 6r; cat # 5612f602; lot # ycn3d triathlon hinge bplate size 6; cat # 5612b600; lot # tt76b triath symmetric x3 patella; cat # 5550-g-391-e; lot # xk6m triath tritnum ctr femcone aug sz 6 r; cat # 5549-a-662; lot # ggxv1 triathlon sym cone aug sz e; cat # 5549-a-150; lot # w4mg1 tri press-fit stem 17mm x 100mm; cat # 5565-s-017; lot # 0126084d tri press-fit stem 19x150mm; cat # 5566-s-019; lot # 0101400e it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

• Brand Name: TRIATH HINGE INSERT SIZE 6 11MM
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50422113
• Report Number: 0002249697-2026-00752
• Device Sequence Number: 9178095
• Product Code: KRO
• UDI-Device Identifier: 07613327601954
• UDI-Public: 07613327601954
• 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: 2024
• 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-611
• Device Lot Number: L06H63
• 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: 02/27/2024
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 225 LB