MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #4R; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER

Catalog Number	5517F402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	01/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: it was reported that the patient's right knee was revised due to a femoral periprosthetic fracture.A cr femur and insert were revised to a ts femur and insert with stem and augments.Rep confirmed that there are no allegations against the revised insert, and 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 has been similar event(s) for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event an event regarding periprosthetic fracture involving a triathlon femoral component was reported.The event was not confirmed.Method & results -product evaluation and results: the reported device was not returned; however, photographs were provided for review.The photographs show a recently explanted femoral component covered in blood and pieces of bone/tissue.No obvious damage is visible on the device.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to periprosthetic fracture of the femur.The reported device was not returned; however, photographs were provided for review.The photographs show a recently explanted femoral component covered in blood and pieces of bone/tissue.No obvious damage is visible on the device.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON P/A CR BEADED #4R
• 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: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; +353 2018315000
• MDR Report Key: 24298352
• Report Number: 0002249697-2026-00080
• Device Sequence Number: 18491228
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K242831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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 Expiration Date: 06/30/2025
• Device Catalogue Number: 5517F402
• Device Lot Number: LAY6N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2020
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 155 LB