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	Unstable (1667); Use of Device Problem (1670)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: the cement-retained implant has been placed without cement.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
An event regarding the off label use of a triathlon femoral component was reported.Conclusions: it was reported that 'the cement-retained implant has been placed without cement'.A review of the triathlon® knee system surgical protocol compendium triath-sp-30_rev-2_34473, indicated that triathlon cr femoral component, catalog: 5510f202 is a cemented part number and therefore the surgeon should apply bone cement to the implant and/or bone surface in accordance with the standard of care for bone cement application.The reported event is considered to be the result of user error.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25300554
• Report Number: 0002249697-2026-00445
• Device Sequence Number: 9517187
• Product Code: JWH
• UDI-Device Identifier: 07613327040241
• UDI-Public: 07613327040241
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: 72Y4H
• 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: 05/07/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 10/02/2026
• 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 Sex: Unknown