MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR FEMUR NO 5 LM/RL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	5610-F-501
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: "doctor contacts stryker personnel to inform that the pkr femur component has broken inside of patient.Patient has been sent for re-surgery, not yet operated.Surgery planned for january.Primary surgery was made 20210415, surgery performed with no problems.Left knee, size 5 femur component, size 4 tibia component and 8mm liner inserted.".
Event or Problem Description
No new information.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a triathlon femoral component was reported.The event was confirmed via clinician review.Method & results: -device evaluation and results: not performed as device remained implanted.-clinician review: a review of the provided medical records by a clinical consultant indicated: "the femoral component shows what appears to be a very slight notch in the mid portion of the concave surface.Confirmation of event: i can confirm that the patient had a primary medial unicompartmental pkr since i was able to review x-rays with the implant in place.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of mechanical failure of a partial knee replacement of femoral component are multifactorial including surgical technique in the position and fixation of the implants.Also contributing our patient factors including activity level, lifestyle and bmi, and bone quality.Especially with osteonecrosis the surrounding bone may be suboptimal for fixation.The patient does have a history of ankylosing spondylitis, taking monthly injections of immunomodulating drugs.This could be a factor in reducing the fixation capability.Implant factors could also play a role but i would not assign any causality to the implant itself unless it can be retrieved and examined by stryker engineers to determine whether or not there is any material defect." -device history review: a review of the device history records could not be performed as lot code information was unknown.-complaint history review: a complaint history review could not be performed as lot code information was unknown.Conclusions: clinician review confirmed that the femoral component shows what appears to be a very slight notch in the mid portion of the concave surface.The reported event was confirmed.The clinician review indicated that "the root cause of this event cannot be determined with certainty.The causes of mechanical failure of a partial knee replacement of femoral component are multifactorial including surgical technique in the position and fixation of the implants.Also contributing our patient factors including activity level, lifestyle and bmi, and bone quality.Especially with osteonecrosis the surrounding bone may be suboptimal for fixation.The patient does have a history of ankylosing spondylitis, taking monthly injections of immunomodulating drugs.This could be a factor in reducing the fixation capability.Implant factors could also play a role but i would not assign any causality to the implant itself unless it can be retrieved and examined by stryker engineers to determine whether or not there is any material defect." 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 PKR FEMUR NO 5 LM/RL
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/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: brad curtis ; 325 corporate drive; mahwah, NJ NA ; +353 2018315000
• MDR Report Key: 24073337
• Report Number: 0002249697-2026-00022
• Device Sequence Number: 21177358
• Product Code: HRY
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K242831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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 Catalogue Number: 5610-F-501
• Device Lot Number: NOT AVAILABLE
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 05/27/2026
• 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: Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 233 LB