MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #6 PS ALLPOLY 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5535A609
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Fibrosis (3167)
Date of Event	05/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject had primary tlka and was found to have limited rom at about 80 degrees despite physical therapy.Mua was performed getting extension to 130 degrees.Clinic visit post mua with rom at 115 degrees extension.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Corrected data: lot#, expiration date, manufacturing date.An event regarding arthrofibrosis involving a triathlon insert was reported.The event was confirmed.Method & results: -product evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device remained implanted.-clinician review: a review of medical records by a clinical consultant indicated "conclusion of assessment: summary: please see relevant clinical history and timelines above.Confirmation of event: i can confirm that the patient had a primary left cemented triathlon total knee arthroplasty with an all polyethylene tibial component since i was able to see an x-ray with the implant in place and review the operation report.I can also confirm that the patient underwent manipulation under anesthesia and injection of the knee since i was able to review the operation report.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of arthrofibrosis following total arthroplasty or multifactorial including surgical technique in the way the implants are positioned and aligned and whether or not restoration of proper kinematics of the knee was carried out.Patient factors including whether or not the patient followed postoperative physical therapy instructions for regaining range of motion is important as well as the patient¿s activity level, lifestyle and bmi.In addition, some patients are genetically prone to scar formation.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 events for the lot referenced.Conclusion: 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 primary/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 additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON #6 PS ALLPOLY 9MM
• 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 NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22989893
• Report Number: 0002249697-2025-00953
• Device Sequence Number: 21049994
• Product Code: MBH
• UDI-Device Identifier: 07613327043655
• UDI-Public: 07613327043655
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: 01/31/2024
• Device Catalogue Number: 5535A609
• Device Lot Number: 439281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2019
• 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: Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White