MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT NO 2 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531-G-209-E
Medical Device Problem Codes	Unstable (1667); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Joint Laxity (4526)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient suspect pcl torn.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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
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 with clinical consultant indicated "conclusion/assessment: no medical records, patient history, sequential x-rays or exams were provided for review.Based on the pi report and unlabeled/undated x-rays, a patient had a tka in 2022.They complained of the knee feeling loose after some undisclosed chiropractic treatment.There was suspicion of a pcl tear but the reasoning for this was not provided.A revision was performed (no record of the procedure specifics) (b)(6) 2025.Event confirmation: a ¿loose knee¿, tearing of the pcl, and/or revision knee surgery cannot be confirmed with the materials provided for review.Root cause: the root cause of the revision would be knee instability, the presumed reason for the instability would be pcl disruption and/or trauma from chiropractic treatment.But these events were not confirmed therefore a root cause cannot be ascribed." 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 been no other similar events for the lot referenced.Conclusions: a review with clinical consultant indicated "conclusion/assessment: no medical records, patient history, sequential x-rays or exams were provided for review.Based on the pi report and unlabeled/undated x-rays, a patient had a tka in 2022.They complained of the knee feeling loose after some undisclosed chiropractic treatment.There was suspicion of a pcl tear but the reasoning for this was not provided.A revision was performed (no record of the procedure specifics) (b)(6) 2025.Event confirmation: a ¿loose knee¿, tearing of the pcl, and/or revision knee surgery cannot be confirmed with the materials provided for review.Root cause: the root cause of the revision would be knee instability, the presumed reason for the instability would be pcl disruption and/or trauma from chiropractic treatment.But these events were not confirmed therefore a root cause cannot be ascribed." 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 NO 2 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23708909
• Report Number: 0002249697-2025-01406
• Device Sequence Number: 13422164
• Product Code: MBH
• UDI-Device Identifier: 07613327336412
• UDI-Public: 07613327336412
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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: 5531-G-209-E
• Device Lot Number: LLL057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown