MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON REVISION INSERT X3 SZ3 11MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	5612-X-311
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon fem dist aug 10mm size 2 left; cat # 5541-a-201; lot # s4z4d.Triath fem distal aug 5mm - size 2 left; cat # 5540-a-201; lot # sga9t.Tri cemented stem 12mmx50mm; cat # 5560-s-112; lot # 1203242k.Triathlon stem extender 25mm; cat # 5571-s-025; lot # r0061h.Tri ts femur sz2 left; cat # 5512-f-201; lot # te44e.Triathlon hinge b/plate size 3; cat # 5612b300; lot # 49l2p.Tri cemented stem 12mmx50mm; cat # 5560-s-112; lot # 1832926j.Simplex hv us 1 pack; cat # 6194-1-001; lot # 527ab826eg; qty: 4.Simplex hv us 1 pack; cat # 6194-1-001; lot # 527ab826eg.Simplex hv us 1 pack; cat # 6194-1-001; lot # 527ab826eg.Simplex hv us 1 pack; cat # 6194-1-001; lot # 527ab826eg.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: total knee revision case.After surgery, patient knee became infected.Took out 3x11 revision poly insert and replaced another 3x11 revision poly insert.Note: rep confirmed that prior revision was not a revision of stryker implants.

• Brand Name: TRIATHLON REVISION INSERT X3 SZ3 11MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 25518389
• Report Number: 0002249697-2026-00518
• Device Sequence Number: 10013606
• Product Code: KRO
• UDI-Device Identifier: 07613327559903
• UDI-Public: 07613327559903
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K230416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

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: 5612-X-311
• Device Lot Number: J51900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female