MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah TRIATH REVISION INSERT X3 SZ2 16MM; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Catalog Number	5612-X-216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: i&d with insert exchange of a right knee due to infection.He revised from a 2x16 to a 2x13 for better range of motion.
Additional Manufacturer Narrative
The following devices were also listed in this report: tri ts femur sz2 right; cat # 5512-f-202; lot # rth3a.Triath fem dist aug 10mm size 2 right; cat # 5541-a-202; lot # shx4t.Triath fem distal aug 5mm - size 2 right; cat # 5540-a-202; lot # sds7y.Triathlon hinge bplate size 2; cat # 5612b200; lot # 99b9r.Tri press-fit stem 18mm x 100mm; cat # 5565-s-018; lot # 0141507a.Tri press-fit stem 14mm x 100mm; cat # 5565-s-014; lot # 0143107h.Triath asymmetric x3 patella; cat # 5551-g-299-e; lot # rdk7.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 that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

• Brand Name: TRIATH REVISION INSERT X3 SZ2 16MM
• 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: 50896098
• Report Number: 0002249697-2026-00895
• Device Sequence Number: 21523003
• Product Code: KRO
• UDI-Device Identifier: 07613327559736
• UDI-Public: 07613327559736
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K230416
• 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
• Report Date (Section B): 09/25/2026

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-216
• Device Lot Number: 814A71
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2025
• 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: Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female