MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5532-G-309-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The following devices were also listed in this report: cat#: 5516f302; triathlon p/a ps beaded #3r; lot#: ncn4r.Cat#: 5536b300; tritanium bplate triathlon s3; lot#: ctd55092.Cat#: 5552-l-350; tritanium patella-asymmetric; lot#: pee01.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Pt.Reported; in regard to a recall that you currently have and i just recently found out i've been having a lot of issues with my knee i had double knee replacement but the number that's on my knee that i'm looking at the surgical paperwork is log: 423-8566.Additional info.7/29/2025: pt stated they have been experiencing pain & swelling since they had their right knee procedure on (b)(6) 2021 which has made it difficult to walk.
Additional Manufacturer Narrative
Reported event: an event regarding pain involving a triathlon insert was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient underwent a primary right cementless robotically assisted total knee arthroplasty on (b)(6) 2021.Since i was able to review the operation report.I have no other information that i can confirm.Root cause analysis: the root cause of this ¿event¿ cannot be determined with certainty since the event itself is unclear.Causes of pain and difficulty walking following a cementless total knee arthroplasty are multifactorial, including surgical technique, patient activity level, lifestyle, and bmi.With the information provided i would not assign any causality to the implant itself." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar event s for the lot referenced.Conclusions: the patient reported pain and swelling.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient underwent a primary right cementless robotically assisted total knee arthroplasty on (b)(6) 2021 since i was able to review the operation report.I have no other information that i can confirm.Root cause analysis: the root cause of this ¿event¿ cannot be determined with certainty since the event itself is unclear.Causes of pain and difficulty walking following a cementless total knee arthroplasty are multifactorial, including surgical technique, patient activity level, lifestyle, and bmi.With the information provided i would not assign any causality to the implant itself." furthermore, it has been confirmed that there have been no recalls associated with this device.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
No new information.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NJ NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22813994
• Report Number: 0002249697-2025-00876
• Device Sequence Number: 8703821
• Product Code: MBH
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2026

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: 12/31/2025
• Device Catalogue Number: 5532-G-309-E
• Device Lot Number: N189VT
• 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): Follow-Up
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2020
• 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: Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 145 LB