MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #4L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5517F401
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Scar Tissue (2060); Inadequate Osseointegration (2646); Arthrofibrosis (4885)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Femoral revision of cementless cr component.Surgeon states reason for femoral revision is arthrofibrosis however the picture of the x-ray shows a possible deep distal resection (implant not in contact completely with bone).The primary replacement was completed with mako on the (b)(6) 2024.
Additional Manufacturer Narrative
Reported event: an event regarding arthrofibrosis involving a triathlon femoral component was reported.The event was not confirmed.Surgeon states reason for femoral revision is arthrofibrosis however the picture of the x-ray shows a possible deep distal resection.This was confirmed by review of 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: i can confirm that the patient had a primary cementless triathlon tritanium cr total knee arthroplasty since i was able to see a radiograph with the implant in place.I cannot directly confirm that the patient had a revision since i have no documentation for this except it was mentioned in the product inquiry summary.I cannot confirm that the patient had arthrofibrosis since i have no documentation except the summary.I can confirm the lack of contact between the distal femoral resection and the implant since i reviewed an x-ray with the lack of contact.Root cause analysis: the root cause of these events cannot be determined with certainty.The root causes of arthrofibrosis or multifactorial including surgical technique factors, especially in the way the implants are positioned and aligned, as well as whether or not proper kinematics of the knee were restored.Patient factors including the possibility of the patient being a scar former can contribute as well as whether or not the patient complied with postoperative recommendations for physical therapy and restoration of range of motion.Patient factors including lifestyle, activity level and bmi can also play a role.With the information provided i would not assign any causality to the implant itself.The root cause of lack of contact of the host bone with the implant are most likely due to surgical factors, such as implantation technique or bone preparation technique.Patient factors and implant factors would not play a role.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to arthrofibrosis.It was also noted that 'the picture of the x-ray shows a possible deep distal resection'.A review of the provided medical records by a clinical consultant indicated: i can confirm that the patient had a primary cementless triathlon tritanium cr total knee arthroplasty since i was able to see a radiograph with the implant in place.I cannot directly confirm that the patient had a revision since i have no documentation for this except it was mentioned in the product inquiry summary.I cannot confirm that the patient had arthrofibrosis since i have no documentation except the summary.I can confirm the lack of contact between the distal femoral resection and the implant since i reviewed an x-ray with the lack of contact.Root cause analysis: the root cause of these events cannot be determined with certainty.The root causes of arthrofibrosis or multifactorial including surgical technique factors, especially in the way the implants are positioned and aligned, as well as whether or not proper kinematics of the knee were restored.Patient factors including the possibility of the patient being a scar former can contribute as well as whether or not the patient complied with postoperative recommendations for physical therapy and restoration of range of motion.Patient factors including lifestyle, activity level and bmi can also play a role.With the information provided i would not assign any causality to the implant itself.The root cause of lack of contact of the host bone with the implant are most likely due to surgical factors, such as implantation technique or bone preparation technique.Patient factors and implant factors would not play a role.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, 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.
Event or Problem Description
No new information.

• Brand Name: TRIATHLON P/A CR BEADED #4L
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22140264
• Report Number: 0002249697-2025-00592
• Device Sequence Number: 8140252
• Product Code: MBH
• UDI-Device Identifier: 07613327040937
• UDI-Public: 07613327040937
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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: 5517F401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 10/27/2025
• 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: 68 YR
• Patient Sex: Female