MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #6 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER

Catalog Number	5531G611
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The following information was provided: the patient had an index right tka on (b)(6), 2017.The patient developed instability and was revised on (b)(6) 2024.Only the poly was exchanged, plus the patella was resurfaced.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding instability 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 was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: no medical records, patient history, or other medical data were provided for review outside of the primary and revision operative notes and unlabeled x-rays.By report the patient underwent a revision knee arthroplasty for instability.This was not well-described in the operative note other than noting mechanical complication.A new polyethylene was placed thus increasing the articular surface by 3 mm.The patella was also resurfaced.The stability of the knee was not described.No complications could be attributed to the patient's outcome at this point.Event confirmation: confirmation: a revision knee arthroplasty, polyethylene exchange and patellar resurfacing, can be confirmed from x-rays and an operative note as well as the patient pi report.Root cause: the root cause for the presumed pain and reported instability cannot be ascertained from the data provided." -product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have ben no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to instability.A review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: no medical records, patient history, or other medical data were provided for review outside of the primary and revision operative notes and unlabeled x-rays.By report the patient underwent a revision knee arthroplasty for instability.This was not well-described in the operative note other than noting mechanical complication.A new polyethylene was placed thus increasing the articular surface by 3 mm.The patella was also resurfaced.The stability of the knee was not described.No complications could be attributed to the patient's outcome at this point.Event confirmation: confirmation: a revision knee arthroplasty, polyethylene exchange and patellar resurfacing, can be confirmed from x-rays and an operative note as well as the patient pi report.Root cause: the root cause for the presumed pain and reported instability cannot be ascertained from the data provided." further information such as return of the device, pathology reports, pre- and post-operative x-rays 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: X3 TRIATHLON CS INSERT #6 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER
• 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: anna ryan ; raheen business park; limerick, FL NA ; EI NA ; +353 9546280700
• MDR Report Key: 23830683
• Report Number: 0002249697-2025-01490
• Device Sequence Number: 5093915
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K242831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: 07/31/2021
• Device Catalogue Number: 5531G611
• Device Lot Number: LFC899
• 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): Initial
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2016
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 160 LB