MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #3 PS ALLPOLY 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5535A313
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthrofibrosis (4885)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: device name# triathlon ps fem component cemented; cat# 5515-f-402; lot# unknown device name# symmetric patella; cat# 5550-l-399; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Subject had a right tka which was followed by an mua for arthrofibrosis.Stryker component lot numbers are not available for the femoral and tibial components.As noted in mua op report: patient presented to the orthopedic clinic with stiffness s/p tka despite adequate pain control and pt.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
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 remains implanted.-clinician review: a review of medical records with a clinical consultant indicated "confirmation of event: i can confirm that the patient underwent both a primary right total knee arthroplasty and a manipulation of that knee since i was able to review the operation reports and x-rays including a five-year follow up x-ray.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of arthrofibrosis requiring manipulation under anesthesia are multifactorial including surgical technique in the way that the implants are sized, positioned and aligned, as well as whether or not proper kinematics of the knee were restored.Patient factors including the ability to follow postoperative instructions with physical therapy plays a role, as well as the patient¿s activity level, lifestyle and bmi.Additionally there are patients who are genetically prone to scar formation.With the information provided, i would not assign any causality to the implant itself." -device history review: could not be performed as lot code information was unknown.-complaint history review: could not be performed as lot code information was unknown.Conclusion: a review of medical records with a clinical consultant indicated "confirmation of event: i can confirm that the patient underwent both a primary right total knee arthroplasty and a manipulation of that knee since i was able to review the operation reports and x-rays including a five-year follow up x-ray.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of arthrofibrosis requiring manipulation under anesthesia are multifactorial including surgical technique in the way that the implants are sized, positioned and aligned, as well as whether or not proper kinematics of the knee were restored.Patient factors including the ability to follow postoperative instructions with physical therapy plays a role, as well as the patient¿s activity level, lifestyle and bmi.Additionally there are patients who are genetically prone to scar formation.With the information provided, i would not assign any causality to the implant itself." if further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TRIATHLON #3 PS ALLPOLY 13MM
• 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: 23220734
• Report Number: 0002249697-2025-01066
• Device Sequence Number: 8872265
• Product Code: MBH
• UDI-Device Identifier: 07613327043556
• UDI-Public: 07613327043556
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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 Catalogue Number: 5535A313
• Device Lot Number: UNKNOWN
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 11/04/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American