MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE6 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531-G-613-E
Medical Device Problem Codes	Difficult to Insert (1316); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
Primary procedure, left knee.It was reported that when handing the insert to the surgeon, or staff said the locking wire looked unusual.When implanting the insert, one side of the locking wire locked, and the other was sitting up (not locking).A second insert was obtained to complete the procedure successfully with no delay.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Corrected data: manufacturing and expiration dates an event regarding assembly issues involving a triathlon insert was reported.The event was not confirmed.Damage was confirmed based on visual inspection of provided photograph.Method & results: -product evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs show an insert with damage to the locking wire.-clinician review: no medical records were received for review with a clinical consultant.-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 'primary procedure, left knee.It was reported that when handing the insert to the surgeon, or staff said the locking wire looked unusual.When implanting the insert, one side of the locking wire locked, and the other was sitting up (not locking).A second insert was obtained to complete the procedure successfully with no delay.Rep confirmed that no further information will be released by the hospital or surgeon.' the reported device was not returned however photographs were provided for review.The photographs show an insert with damage to the locking wire.No further investigation for this event is possible at this time as no devices was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
No new information.

• Brand Name: X3 TRIATHLON CS INS SIZE6 13MM
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22663106
• Report Number: 0002249697-2025-00743
• Device Sequence Number: 7533938
• Product Code: MBH
• UDI-Device Identifier: 07613327337761
• UDI-Public: 07613327337761
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5531-G-613-E
• Device Lot Number: VH4A4P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2023
• 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
• Patient Age: 58 YR
• Patient Sex: Male