MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah TRITANIUM BPLATE TRIATHLON S1; prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal

Catalog Number	5536B100
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: due to loosening following tka, all implants were removed and a revision procedure was performed.

• Brand Name: TRITANIUM BPLATE TRIATHLON S1
• 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-Limerick; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50101872
• Report Number: 0002249697-2026-00659
• Device Sequence Number: 18654739
• Product Code: JWH
• UDI-Device Identifier: 07613327041477
• UDI-Public: 07613327041477
• 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: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2026

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: 5536B100
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 07/31/2026
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Race: Asian