MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah TRIATH REVISION INSERT X3 SZ5 11MM; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Catalog Number	5612-X-511
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: it was reported that the patient's left knee was revised due to stiffness.A 5x11 triathlon revision ts insert was revised to a 5x9 ts revision insert.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
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 SZ5 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: 50880739
• Report Number: 0002249697-2026-00884
• Device Sequence Number: 21288536
• Product Code: KRO
• UDI-Device Identifier: 07613327560138
• UDI-Public: 07613327560138
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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-511
• Device Lot Number: ERPLS9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male