MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT CEMENTED; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER

Catalog Number	5515-F-402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: left tka case using navigation.Implant plan was changed intraoperatively from femoral cr to ps.Due to prolonged surgery, the team was under time pressure.Both left and right implants were stored in the anteroom.The double-check with the surgeon prior to opening was skipped.During verbal confirmation, ¿right¿ was read aloud but not recognized as an error.The implant was inserted without resistance, and the surgeon did not notice the laterality error.The issue was not identified during x-ray confirmation.The error was identified afterward when the implant label (¿right¿) was checked.On the same day, the patient underwent reoperation and the implant was replaced with the correct one.Revision surgery was completed without complications.

• Brand Name: TRIATHLON PS FEM COMPONENT CEMENTED
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 25725252
• Report Number: 0002249697-2026-00570
• Device Sequence Number: 12184410
• Product Code: JWH
• UDI-Device Identifier: 07613327050370
• UDI-Public: 07613327050370
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K242831
• 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): 07/06/2026

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: 5515-F-402
• Device Lot Number: SAV42D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian