MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER

Catalog Number	5530-G-609-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: device name triathlon p/a cr beaded #6r; cat# 5517f602; lot# rxy7r device name triathlon asymmetric x3 patella; cat# 5551-g-350-e; lot# x2yd unknown triathlon baseplate: cat# unknown; lot# unknown it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
The following information was provided: patient had initial right knee replacement done (b)(6) 2025 at (b)(6) hospital by dr (b)(6) (oa: (b)(4)).Patient has presented with infection in knee at (b)(6) hospital.On (b)(6) 2025 all implants in right knee were all removed and a cement spacer placed.This is the first stage of a 2 stage revision.No surgical delay, implants removed without further damage to remaining bone.Swabs, micro & histology samples all taken for testing.Patient male, 79 years.Additional information provided 23/10/2025: there were no implants implanted yesterday.Only a cement spacer with antibiotics, which will be revised in 6-8 weeks, pending the resolution of the infection.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: joann ripoli ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 23543750
• Report Number: 0002249697-2025-01336
• Device Sequence Number: 9449446
• Product Code: JWH
• UDI-Device Identifier: 07613327383133
• UDI-Public: 07613327383133
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K242831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2025

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-609-E
• Device Lot Number: V225E4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2024
• 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 Age: 79 YR
• Patient Sex: Male