MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah TRIATHLON CR FEM COMP #2 R-CEM; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer

Catalog Number	5510F202
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: revision of r triathlon cr femoral component due to patient pain.Successfully completed.Notification only.

• Brand Name: TRIATHLON CR FEM COMP #2 R-CEM
• 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-Limerick; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 24979784
• Report Number: 0002249697-2026-00335
• Device Sequence Number: 10468296
• Product Code: JWH
• UDI-Device Identifier: 07613327040241
• UDI-Public: 07613327040241
• Combination Product (Y/N): N
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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: 5510F202
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 09/28/2026
• 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: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female