MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CEMENTED STEM-15MM X 100MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER

Catalog Number	5560-S-215
Medical Device Problem Codes	Loss of Osseointegration (2408); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Insufficient Information (4580)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
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
The following information was provided: it was reported that the patient's left knee was revised due to the stem becoming loose/ unthreading from the femoral component (rep confirmed threads/ implants were not broken).The femoral component, stem, and liner were revised.Rep confirmed that there were no allegations against the revised liner, and that no further information will be released by the hospital or surgeon.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a triathlon stem was reported.The event was confirmed via review of the medical records by a clinician.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: confirmation of event: i can't confirm that the patient had implantation of a triathlon ts arthroplasty since i was able to review the x-rays.I can also confirm that there was disruption of the stem extension from the femoral housing/boss since the angulation can be clearly seen on the x-ray.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of "loosening/unthreading" of a cemented federal stem extension or multi factorial including surgical technique in the way it is prepared and assembled, patient factors including lifestyle, activity level and bmi, and implant factors.-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's left knee was revised due to the stem becoming loose/ unthreading from the femoral component (rep confirmed threads/ implants were not broken).A review of the provided medical records by a clinical consultant indicated: confirmation of event: i can't confirm that the patient had implantation of a triathlon ts arthroplasty since i was able to review the x-rays.I can also confirm that there was disruption of the stem extension from the femoral housing/boss since the angulation can be clearly seen on the x-ray.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of "loosening/unthreading" of a cemented federal stem extension or multi factorial including surgical technique in the way it is prepared and assembled, patient factors including lifestyle, activity level and bmi, and implant factors.

• Brand Name: TRIATHLON CEMENTED STEM-15MM X 100MM
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24443727
• Report Number: 0002249697-2026-00143
• Device Sequence Number: 13353160
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K242831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

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: 05/31/2021
• Device Catalogue Number: 5560-S-215
• Device Lot Number: 0044146J
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2016
• 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 Age: 64 YR
• Patient Sex: Male