MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5532-G-411-E
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When placing the final insert, a small wire was noticed.Despite this, it was positioned on the tibial base, but it was not properly seated.In the end, it was decided to replace it due to the risk of loosening.
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.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.
Additional Manufacturer Narrative
An event regarding damage involving a triathlon insert was reported.The event was confirmed.Method & results -product evaluation and results: visual inspection: inspection of the returned insert indicated the damage on the circumference of the insert.Poly debris observed consistent with several assembly attempts.Material analysis: material analysis for the device was not performed as this aspect was not in question.-clinician review: no medical records were received for review with clinical consultant.-product history review: review of the device history records indicate 23 devices were manufactured and accepted into final stock on 09 mar 2023 with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: visual inspection: inspection of the returned insert indicated the damage on the circumference of the insert.Poly debris observed consistent with several assembly attempts.Material analysis: material analysis for the device was not performed as this aspect was not in question.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: TRIATHLON PS X3 TIBIAL INSERT
• 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: 21940910
• Report Number: 0002249697-2025-00461
• Device Sequence Number: 9055881
• Product Code: MBH
• UDI-Device Identifier: 07613327338607
• UDI-Public: 07613327338607
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: 5532-G-411-E
• Device Lot Number: 9644EY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 76 KG