MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah X3 TRIATH INSERT CR NUM5 10MM; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Co

Catalog Number	5530-G-510-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	08/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the sales rep that the patient underwent a mako total knee replacement (tkr) on (b)(6) 2026 and was subsequently admitted on (b)(6) 2026 due to septic arthritis.According to the inpatient report, the condition was most likely due to a streptococcal prosthetic joint infection (pji).A liner exchange procedure was performed on (b)(6) 2026 at 1250 hrs.The original triathlon x3 tibial bearing insert ¿ cr, size 5, 10 mm was explanted and replaced with an identical triathlon x3 tibial bearing insert ¿ cr, size 5, 10 mm with lot: l66atj.
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 similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

• Brand Name: X3 TRIATH INSERT CR NUM5 10MM
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50460765
• Report Number: 0002249697-2026-00777
• Device Sequence Number: 10172229
• Product Code: MBH
• UDI-Device Identifier: 07613327391176
• UDI-Public: 07613327391176
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K173849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: 5530-G-510-E
• Device Lot Number: 5D3JW8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/02/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2025
• 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