MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah TRIATHLON CR FEM COMP 3 R-CEM; prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal

Catalog Number	5510F302
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Discomfort (2330); Insufficient Information (4580)
Date of Event	06/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: during a knee replacement procedure, a femoral component with the opposite laterality to that required for the patient was opened and implanted.The event was attributed to human error during the verification, product opening, and surgical assistance processes performed by the hospital's surgical staff.It was confirmed that neither the mako system nor the implanted device exhibited any quality defect, malfunction, or performance-related issue that contributed to the event.Following identification of the error, a second surgical procedure was scheduled and performed on the same day, approximately four hours later, to implant the appropriate knee revision prosthesis based on the patient's clinical needs.The incorrect femoral component was removed and replaced with the appropriate revision implant.

• Brand Name: TRIATHLON CR FEM COMP 3 R-CEM
• Common Device Name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal
• Manufacturer (Section D): Stryker Orthopaedics-Mahwah; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): Stryker Orthopaedics-Limerick; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; +1(954)628-0700
• MDR Report Key: 50035579
• Report Number: 0002249697-2026-00650
• Device Sequence Number: 13393634
• Product Code: JWH
• UDI-Device Identifier: 07613327040265
• UDI-Public: 07613327040265
• Combination Product (Y/N): N
• Initial Reporter Country: PR
• PMA/510(K) Number: K242831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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: 5510F302
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 07/27/2026
• 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: Female