MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT NO 6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER

Catalog Number	5531-G-609-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding infection involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: a review of the device history records could not be performed as lot code information was unknown.Complaint history review: a complaint history review could not be performed as lot code information was unknown.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including lot details, pathology reports, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.All stryker products are sold as sterile either by being validated to a minimum sterility assurance level sal of 10^-6 or aseptically filled under a validated process in accordance with applicable external standards if devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.As no device details were supplied, it is not possible to determine if the patient¿s implant is subject to a recall.
Event or Problem Description
Revised a stryker knee (left ).The 6x9 cs insert is being revised due to infection.He replaced it with another 6x 9mm cs poly.No visible signs of damage nor wear.No intel on original implantation date.

• Brand Name: X3 TRIATHLON CS INSERT NO 6 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24627645
• Report Number: 0002249697-2026-00199
• Device Sequence Number: 9015232
• Product Code: JWH
• UDI-Device Identifier: 07613327337402
• UDI-Public: 07613327337402
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K242831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2026

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: 5531-G-609-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown