MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah X3 TRIATH INSERT PSR NUM3 9MM; Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, co

Catalog Number	8532-G-309-E
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient who underwent tka in january this year developed a postoperative infection, and the insert was replaced.

• Brand Name: X3 TRIATH INSERT PSR NUM3 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50442445
• Report Number: 0002249697-2026-00769
• Device Sequence Number: 13332535
• Product Code: MBH
• UDI-Device Identifier: 07613327481303
• UDI-Public: 07613327481303
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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: 8532-G-309-E
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/25/2026
• 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; Hospitalization
• Patient Sex: Unknown