MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G309
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "please find attached pictures of a left total knee implant that was revised yesterday.It was reported by the surgeon that the primary surgery was bilateral total knees.The left and right knees are both unstable and the plan is to revise the right knee as well at some point.The revision was secondary to instability of the joint and evidence of loosening on bone scan and x-ray.An incision was made and when the knee was flexed it was discovered that the femoral implant was broken.The joint was revised to a competitor revision prosthesis.These implants have been retained and i will be shipping them to stryker.Please send return information and i will return as soon as they are decontaminated.No further information is available from the surgeon or hospital." rep confirmed that he and the surgeon request investigation results.
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.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event an event regarding instability and wear involving a triathlon insert was reported.The wear event was confirmed through evaluation of the returned device.Instability was not confirmed.Method & results product evaluation and results: visual inspection: visual inspection of the returned device indicated that the insert is worn.The damage present on the posterior portion was consistent with delamination and material loss due to articulation.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations, which are common damage modes of uhmwpe.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.Clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: it was reported that the patient was revised due to instability.Visual inspection of the returned device indicated that the insert is worn.The damage present on the posterior portion was consistent with delamination and material loss due to articulation.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations, which are common damage modes of uhmwpe.Burnishing is caused by adhesive/abrasive wear of the insert against the femoral component.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.Instability cannot be confirmed as insufficient information was provided.Further information such as pre- and post-operative x-rays, primary 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 become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: X3 TRIATHLON CS INSERT #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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22850815
• Report Number: 0002249697-2025-00893
• Device Sequence Number: 19955337
• Product Code: MBH
• UDI-Device Identifier: 07613327045727
• UDI-Public: 07613327045727
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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 Expiration Date: 08/31/2022
• Device Catalogue Number: 5531G309
• Device Lot Number: LGC736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2017
• 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: 55 YR
• Patient Sex: Female