MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 6 TRIATH TS PLUS TIB INS X3 POLY 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER

Catalog Number	5537-G-609-E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: pt had a triathlon ts knee surgery to his left knee done 6 weeks ago.Orthopaedic registrar, messaged me this morning saying that the pt needed a washout and insert exchange for source control of an infection in his left knee as he has been febrile and has confirmed bacteria in his knee.The patient is booked to have the insert exchange done on thursday (b)(6) 2025.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a triathlon insert was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: no medical records, patient histories, sequential x-rays, or operative notes were provided for a review.Based solely on the event description and unlabeled/undated x-rays; a patient was proposed for re-operation for infection six weeks postoperatively.The plan was for a polyethylene exchange with wash-out for fever and ¿confirmed¿ bacteria within the knee.Event confirmation: the event, a revision arthroplasty for infection, cannot be confirmed without additional medical information.Root cause: the root cause for the proposed revision would be infection as based on the event description.However, the event cannot be confirmed thus a root cause cannot be attributed." -product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot or sterile lot referenced.Conclusions: it was reported that the patient was revised due to infection.All stryker products are sold as sterile either by being validated to a minimum sterility assurance level sal of 10^-6 or aseptically filled under a validated process in accordance with applicable external standards.A review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: no medical records, patient histories, sequential x-rays, or operative notes were provided for a review.Based solely on the event description and unlabeled/undated xrays; a patient was proposed for re-operation for infection six weeks postoperatively.The plan was for a polyethylene exchange with wash-out for fever and ¿confirmed¿ bacteria within the knee.Event confirmation: the event, a revision arthroplasty for infection, cannot be confirmed without additional medical information.Root cause: the root cause for the proposed revision would be infection as based on the event description.However, the event cannot be confirmed thus a root cause cannot be attributed." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.Correction: d4.

• Brand Name: NO 6 TRIATH TS PLUS TIB INS X3 POLY 9MM
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23453020
• Report Number: 0002249697-2025-01283
• Device Sequence Number: 21061992
• Product Code: JWH
• UDI-Device Identifier: 07613327288162
• UDI-Public: 07613327288162
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: 5537-G-609-E
• Device Lot Number: 6J7VD8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 106 KG