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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/04/2026
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: cat#; device name; lot#: 5521-b-600; tri ts baseplate size 6; sxz4ra.5565-s-016; tri press-fit stem 16mm x 100mm; 143113.5565-s-014; tri press-fit stem 14mm x 100mm; 133694.5543-a-600; tri post augment sz6 5mm; unknown.5540-a-602; triath fem distal aug 5mm - size 6 right; unknown.540-a-602; triath fem distal aug 5mm - size 6 right; 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: the implant was placed in 2025 for knee prosthesis revision following a periprosthetic infection.On (b)(6) 2026, a two-stage revision procedure was performed due to suspected infection of the right knee prosthesis, with implantation of a cement spacer (two-stage right tka revision).The report involves the entire knee prosthesis system, including: 1- femoral component, 2- femoral stem, 3 - tibial component, 4 - tibial stem, 5- tibial insert with post, 6¿7 femoral augments.Implantation date: the exact day is unknown.

• 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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 25304281
• Report Number: 0002249697-2026-00454
• Device Sequence Number: 9368120
• Product Code: JWH
• UDI-Device Identifier: 07613327027389
• UDI-Public: 07613327027389
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K242831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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
• Device Lot Number: Y405HT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2024
• 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: 72 YR
• Patient Sex: Male