MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATH SOLID PS TIB INS TRL SZ 4 - 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5532-T-409Y
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
"posterior part of the poly broke during trialing".Patient had to undergo another surgery to remove the broken part since the patients wound was closed without removing it.Patient had to undergo another surgery to remove the broken part since the patients wound was closed without removing it.And x-ray was used." primary tka, surgical delay in minutes: 45minutes.
Additional Manufacturer Narrative
Correction: upon further review of the information provided, this event has been determined to be non-reportable.A delay in surgery was reported to remove the fragment of the trial device, the procedure was completed successfully, and no injury occurred.Additionally, a review of clinician-approved risk documentation indicates that the highest potential probability of serious incident associated with material fragments is considered negligible.Furthermore, an analysis of complaint history data shows that there have been no reports of serious injury or death resulting from similar events within this device family.Based on this review, it is unlikely that a serious injury or death would result if this event were to recur.Therefore, this event is not reportable.
Event or Problem Description
Update: "the patient was still under anesthesia when they realized a piece was missing.They noticed it straight away when the trial poly came out.".

• Brand Name: TRIATH SOLID PS TIB INS TRL SZ 4 - 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23610273
• Report Number: 0002249697-2025-01354
• Device Sequence Number: 9444512
• Product Code: MBH
• UDI-Device Identifier: 07613327402834
• UDI-Public: 07613327402834
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: 5532-T-409Y
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Other; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female