MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah NO 6 TRIATH TS PLUS TIB INS X3 POLY 9MM; prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal

Catalog Number	5537-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	03/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
"the following devices were also listed in this report: large howmedica bone plug 1pk; cat#: 6215-5-021; lot#: cppaaj04ba.Triathlon cemented stem-15mm x 100mm; cat#: 5560-s-215; lot#: 1142363e.Tri ts femur sz6 left; cat#: 5512-f-601; lot#: rvt7h.Tri post augment sz6 10mm; cat#: 5544-a-600; lot#: obx4v.Tri post augment sz6 5mm; cat#: 5543-a-600; lot#: ox99i.Tri cemented stem 12mmx50mm; cat#: 5560-s-112; lot#: 1194532k.Tri ts baseplate size 6; cat#: 5521-b-600; lot#: oeo9xa.Triathlon fem dist aug 10mm size 6 left; cat#: 5541-a-601; lot#: sei9v.Triath fem distal aug 5mm - size 6 left; cat#: 5540-a-601; lot#: r4b9i.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience." review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There has been similar event(s) for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The following information was provided: hi team, the patient involved in this pi has had further surgery due to infection.I was notified yesterday at 5pm that this patient would be having all implants removed today and a cemented femur and insert inserted to act as a cement spacer.The case was attended by mako specialist from another territory.I have managed to get the following: about 2 weeks ago the patient had a washout of his left knee due to infection.Yesterday, all the implants were removed and the following implanted.Due to hospital policy, the implants were disposed of.As the revision was done because of infection, the doctors are not requiring an investigation.Hospital will not give me access to patient notes or laboratory results.The insert was disposed of according to hospital policy.

• Brand Name: NO 6 TRIATH TS PLUS TIB INS X3 POLY 9MM
• Common Device Name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal
• 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 ; +1(201)831-5000
• MDR Report Key: 24800400
• Report Number: 0002249697-2026-00271
• Device Sequence Number: 10667084
• Product Code: JWH
• UDI-Device Identifier: 07613327288162
• UDI-Public: 07613327288162
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2026

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: 5X7YKN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male