MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT NO 3 9MM; Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, co

Catalog Number	5531-G-309-E
Medical Device Problem Codes	Degraded (1153); Fracture (1260); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Hyperextension (4523); Joint Laxity (4526)
Date of Event	01/04/2026
Type of Reportable Event	Serious Injury
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 similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Patient need revision due to pain.Removing the insert it was discovered that posterior medial "corner" of the insert was broken.Patient had an acl and pcl recontraction many years ago.Patient came for a revision since she heard some noises (clicks) from the left knee and felt that the knee was begun to hyperextend.
Additional Manufacturer Narrative
An event regarding crack/fracture and wear involving a triathlon insert was reported.The event was confirmed via evaluation of the returned device and clinician review of provided medical records.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated a piece of the device has fractured off of the posterior edge.Additional damage to the underside of the insert was observed consistent with removal of the device during explantation.Dimensional and functional inspections were not performed as the device was returned damaged.Clinician review: a review of the provided medical information by a clinical consultant indicated: 'event confirmation: revision surgery for instability and hyperextension can be confirmed from the materials provided.Wear and a small polyethylene fracture was confirmed as well.Root cause: the root cause of the revision was instability.The root cause of the polyethylene failure cannot be determined but was like the result of abnormal stresses due to the instability and/or the hyperextension trauma.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: it was reported that 'patient need revision due to pain.Removing the insert it was discovered that posterior medial "corner" of the insert was broken.' the fracture of the insert was confirmed via evaluation of the returned device.Visual inspection of the returned device indicated a piece of the device has fractured off of the posterior edge.Additional damage to the underside of the insert was observed consistent with removal of the device during explantation.A review of the provided medical information by a clinical consultant indicated: 'event confirmation: revision surgery for instability and hyperextension can be confirmed from the materials provided.Wear and a small polyethylene fracture was confirmed as well.Root cause: the root cause of the revision was instability.The root cause of the polyethylene failure cannot be determined but was like the result of abnormal stresses due to the instability and/or the hyperextension trauma.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.
Event or Problem Description
No new information.

• Brand Name: X3 TRIATHLON CS INSERT NO 3 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-Limerick; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25044851
• Report Number: 0002249697-2026-00355
• Device Sequence Number: 16055023
• Product Code: MBH
• UDI-Device Identifier: 07613327336955
• UDI-Public: 07613327336955
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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: 5531-G-309-E
• Device Lot Number: LLM466
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/28/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2022
• 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 Age: 53 YR
• Patient Sex: Female
• Patient Weight: 162 LB
• Patient Race: White